PART 886—OPHTHALMIC DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted. Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 886.1 Scope. (a) This part sets forth the classification of ophthalmic devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, an ophthalmic device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. [52 FR 33355, Sept. 2, 1987, as amended at 73 FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, 2013] § 886.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. (c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2320, Jan. 14, 2000] Subpart B—Diagnostic Devices § 886.1040 Ocular esthesiometer. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001] § 886.1050 Adaptometer (biophotometer). (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001] § 886.1070 Anomaloscope. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] § 886.1090 Haidinger brush. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007] § 886.1100 Retinal diagnostic software device. (a) Identification. (b) Classification. (1) Software verification and validation documentation, based on a comprehensive hazard analysis, must fulfill the following: (i) Software documentation must provide a full characterization of technical parameters of the software, including algorithm(s). (ii) Software documentation must describe the expected impact of applicable image acquisition hardware characteristics on performance and associated minimum specifications. (iii) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality. (iv) Software documentation must include mitigation measures to manage failure of any subsystem components with respect to incorrect patient reports and operator failures. (2) Clinical performance data supporting the indications for use must be provided, including the following: (i) Clinical performance testing must evaluate sensitivity, specificity, positive predictive value, and negative predictive value for each endpoint reported for the indicated disease or condition across the range of available device outcomes. (ii) Clinical performance testing must evaluate performance under anticipated conditions of use. (iii) Statistical methods must include the following: (A) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification. (B) Statistical analysis must provide confidence intervals for each performance metric. (iv) Clinical data must evaluate the variability in output performance due to both the user and the image acquisition device used. (3) A training program with instructions on how to acquire and process quality images must be provided. (4) Human factors validation testing that evaluates the effect of the training program on user performance must be provided. (5) A protocol must be developed that describes the level of change in device technical specifications that could significantly affect the safety or effectiveness of the device. (6) Labeling must include: (i) Instructions for use, including a description of how to obtain quality images and how device performance is affected by user interaction and user training; (ii) The type of imaging data used, what the device outputs to the user, and whether the output is qualitative or quantitative; (iii) Warnings regarding image acquisition factors that affect image quality; (iv) Warnings regarding interpretation of the provided outcomes, including: (A) A warning that the device is not to be used to screen for the presence of diseases or conditions beyond its indicated uses; (B) A warning that the device provides a screening diagnosis only and that it is critical that the patient be advised to receive followup care; and (C) A warning that the device does not treat the screened disease; (v) A summary of the clinical performance of the device for each output, with confidence intervals; and (vi) A summary of the clinical performance testing conducted with the device, including a description of the patient population and clinical environment under which it was evaluated. [87 FR 3205, Jan. 21, 2022] § 886.1120 Ophthalmic camera. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019] § 886.1140 Ophthalmic chair. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 886.1150 Visual acuity chart. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 886.1160 Color vision plate illuminator. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] § 886.1170 Color vision tester. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 886.1190 Distometer. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 886.1200 Optokinetic drum. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025] § 886.1220 Corneal electrode. (a) Identification. (b) Classification. § 886.1250 Euthyscope. (a) Identification. (b) Classification. (2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 84 FR 71817, Dec. 30, 2019] § 886.1270 Exophthalmometer. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001] § 886.1290 Fixation device. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] § 886.1300 Afterimage flasher. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990] § 886.1320 Fornixscope. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1330 Amsler grid. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1340 Haploscope. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] § 886.1342 Strabismus detection device. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination). (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated: (i) Verification of lowest detectable amount of deviation; and (ii) Validation of the accuracy and precision at the lowest detectable amount of deviation. (3) Software verification, validation, and hazard analysis must be performed. (4) Optical radiation safety testing must demonstrate the device is safe per the directions for use. (5) Performance testing must demonstrate the electromagnetic compatibility of the device. (6) Performance testing must demonstrate the electrical safety of the device. (7) Labeling must include the following: (i) Summaries of non-clinical and clinical performance testing; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanation of all user-interface components; and (iv) Information related to electromagnetic compatibility and optical radiation classification. [81 FR 65280, Sept. 22, 2016] § 886.1350 Keratoscope. (a) Identification. (b) Classification. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 65 FR 2320, Jan. 14, 2000; 90 FR 55990, Dec. 4, 2025] § 886.1360 Visual field laser instrument. (a) Identification. (b) Classification. § 886.1375 Bagolini lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1380 Diagnostic condensing lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens. (a) Identification. (b) Classification. § 886.1390 Flexible diagnostic Fresnel lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1395 Diagnostic Hruby fundus lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1400 Maddox lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1405 Ophthalmic trial lens set. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38811, July 25, 2001] § 886.1410 Ophthalmic trial lens clip. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] § 886.1415 Ophthalmic trial lens frame. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1420 Ophthalmic lens gauge. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] § 886.1425 Lens measuring instrument. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001] § 886.1430 Ophthalmic contact lens radius measuring device. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001] § 886.1435 Maxwell spot. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001] § 886.1450 Corneal radius measuring device. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001] § 886.1460 Stereopsis measuring instrument. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1500 Headband mirror. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1510 Eye movement monitor. (a) Identification. (b) Classification. § 886.1570 Ophthalmoscope. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.1605 Perimeter. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025] § 886.1630 AC-powered photostimulator. (a) Identification. (b) Classification. § 886.1640 Ophthalmic preamplifier. (a) Identification. (b) Classification. § 886.1650 Ophthalmic bar prism. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1655 Ophthalmic Fresnel prism. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1660 Gonioscopic prism. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001] § 886.1665 Ophthalmic rotary prism. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. (b) Classification. § 886.1680 Ophthalmic projector. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001] § 886.1690 Pupillograph. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001] § 886.1700 Pupillometer. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1750 Skiascopic rack. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, 2001] § 886.1760 Ophthalmic refractometer. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, 2001] § 886.1770 Manual refractor. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1780 Retinoscope. (a) Identification. (b) Classification. (2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2320, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019; 90 FR 55991, Dec. 4, 2025] § 886.1790 Nearpoint ruler. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1800 Schirmer strip. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001] § 886.1810 Tangent screen (campimeter). (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1840 Simulatan (including crossed cylinder). (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1850 AC-powered slitlamp biomicroscope. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.1860 Ophthalmic instrument stand. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1870 Stereoscope. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1880 Fusion and stereoscopic target. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55991, Dec. 4, 2025] § 886.1905 Nystagmus tape. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.1910 Spectacle dissociation test system. (a) Identification. (b) Classification. [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.1925 Diurnal pattern recorder system. (a) Identification. (b) Classification. (1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Ability of the device to detect diurnal changes. (ii) Tolerability of the system at the corneoscleral interface in the intended use population. (2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure. (3) Patient-contacting components must be demonstrated to be biocompatible. (4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device. (7) Performance testing must demonstrate electrical safety of the device. (8) Labeling must include the following: (i) Warning against activities and environments that may put the user at greater risk. (ii) Specific instructions for the safe use of the device, which includes: (A) Description of all device components and instructions for assembling the device; (B) Explanations of all available programs and instructions for their use; (C) Instructions and explanation of all user-interface components; (D) Instructions on all safety features of the device; and (E) Instructions for properly maintaining the device. (iii) A summary of nonclinical testing information to describe EMC safety considerations. (iv) A summary of safety information obtained from clinical testing. (v) Patient labeling to convey information regarding appropriate use of device. [81 FR 34270, May 31, 2016] § 886.1930 Tonometer and accessories. (a) Identification. (b) Classification. § 886.1940 Tonometer sterilizer. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 65 FR 2321, Jan. 14, 2000] § 886.1945 Transilluminator. (a) Identification. (b) Classification. (2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019] Subpart C [Reserved] Subpart D—Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998] § 886.3130 Ophthalmic conformer. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998] § 886.3200 Artificial eye. (a) Identification. (b) Classification. [61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001] § 886.3300 Absorbable implant (scleral buckling method). (a) Identification. (b) Classification. § 886.3320 Eye sphere implant. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.3340 Extraocular orbital implant. (a) Identification. (b) Classification. § 886.3400 Keratoprosthesis. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) “Guidance on 510(k) Submissions for Keratoprostheses.” [65 FR 17147, Mar. 31, 2000] § 886.3600 Intraocular lens. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 886.3800 Scleral shell. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998] § 886.3920 Aqueous shunt. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) “Aqueous Shunts—510(k) Submissions.” [65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001] Subpart E—Surgical Devices § 886.4070 Powered corneal burr. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019] § 886.4100 Radiofrequency electrosurgical cautery apparatus. (a) Identification. (b) Classification. § 886.4115 Thermal cautery unit. (a) Identification. (b) Classification. § 886.4150 Vitreous aspiration and cutting instrument. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.4155 Scleral plug. (a) Identification. (b) Classification. (1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; and (iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. (2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; (iii) Characterization of the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and (vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. [78 FR 68715, Nov. 15, 2013] § 886.4170 Cryophthalmic unit. (a) Identification. (b) Classification. § 886.4230 Ophthalmic knife test drum. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.4250 Ophthalmic electrolysis unit. (a) Identification. (b) Classification. (2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019] § 886.4270 Intraocular gas. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 886.4275 Intraocular fluid. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. § 886.4280 Intraocular pressure measuring device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. § 886.4300 Intraocular lens guide. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000] § 886.4320 Corneal storage medium with preservatives including antifungals. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. (i) The following performance characteristics of the cornea following storage in the device must be demonstrated: (A) Endothelial cell density; (B) Endothelial cell morphology; (C) Corneal transparency; and (D) Central corneal thickness. (ii) Antimicrobial activity of the device must be demonstrated at the initial and maximum labeled storage time. (iii) Characterization of all preservatives, including antifungals, must include the following: (A) Characterization of impurities, heavy metal analysis, concentration, and dissolution; and (B) Chemical activity of all preservatives over the labeled use life of the device. (2) Performance data must demonstrate the sterility of the device. (3) The device must be demonstrated to be biocompatible and non-pyrogenic. (4) Performance data must support the claimed shelf life by demonstrating continued sterility, controlled bioburden, package integrity, and device functionality over the intended shelf life. (5) The device and each of its components ( e.g., (6) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. (7) Labeling must include the following instructions: (i) Rinsing of cornea prior to transplantation; and (ii) Complete dissolution of all preservatives. [91 FR 24347, May 6, 2026] § 886.4335 Operating headlamp. (a) Identification. (b) Classification. (2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. [55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019] § 886.4350 Manual ophthalmic surgical instrument. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995; 66 FR 38813, July 25, 2001] § 886.4355 Corneal inlay inserter handle. (a) Identification. (b) Classification. [84 FR 14870, Apr. 12, 2019] § 886.4360 Ocular surgery irrigation device. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001] § 886.4370 Keratome. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990] § 886.4390 Ophthalmic laser. (a) Identification. (b) Classification. § 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. (a) Identification. (b) Classification. [65 FR 6894, Feb. 11, 2000] § 886.4400 Electronic metal locator. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.4440 AC-powered magnet. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.4445 Permanent magnet. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.4570 Ophthalmic surgical marker. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001] § 886.4610 Ocular pressure applicator. (a) Identification. (b) Classification. § 886.4670 Phacofragmentation system. (a) Identification. (b) Classification. § 886.4690 Ophthalmic photocoagulator. (a) Identification. (b) Classification. § 886.4750 Ophthalmic eye shield. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000; 90 FR 55992, Dec. 4, 2025] § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.4790 Ophthalmic sponge. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019] § 886.4855 Ophthalmic instrument table. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001; 90 FR 55992, Dec. 4, 2025] Subpart F—Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. (b) Classification. § 886.5120 Low-power binocular loupe. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.5200 Eyelid thermal pulsation system. (a) Identification. (b) Classification. (1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions; (3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (4) The device should be demonstrated to be biocompatible; and (5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness. [76 FR 51878, Aug. 19, 2011] § 886.5201 Intense pulsed light device for managing dry eye. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate adverse events and improvement of dry eye signs and symptoms under anticipated conditions of use. (2) Thermal safety assessment in a worst-case scenario must be performed to validate temperature safeguards. (3) Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Physician and patient labeling must include: (i) Device technical parameters; (ii) A summary of the clinical performance testing conducted with the device; (iii) A description of the intended treatment area location; (iv) Warnings and instructions regarding the use of safety-protective eyewear for patient and device operator; (v) A description of intense pulse light (IPL) radiation hazards and protection for patient and operator; (vi) Instructions for use, including an explanation of all user interface components; and (vii) Instructions on how to clean and maintain the device and its components. [88 FR 3638, Jan. 20, 2023] § 886.5300 Tear electrostimulation device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. (2) Patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Physician and patient labeling must include: (i) Summaries of electrical stimulation parameters; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanations of all user-interface components; (iv) Information related to electromagnetic compatibility classification; and (v) Instructions on how to clean the device. [82 FR 60116, Dec. 19, 2017] § 886.5305 Electromechanical tear stimulator. (a) Identification. (b) Classification. (1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted: (i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties; (ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and (iii) Use life testing. (3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device. (4) All patient-contacting components of the device must be demonstrated to be biocompatible. (5) Software verification, validation, and hazard analysis must be performed. (6) Physician and patient labeling must include: (i) A detailed summary of the device's technical parameters; (ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement; (iii) Information related to electromagnetic compatibility classification; (iv) Instructions on how to clean and maintain the device; (v) A summary of the clinical performance testing conducted with the device; (vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and (vii) Information on how the device operates and the typical sensations experienced during treatment. [87 FR 9243, Feb. 18, 2022] § 886.5310 Intranasal electrostimulation device for dry eye symptoms. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use. (2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. (3) Patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. (5) Software verification, validation, and hazard analysis must be performed. (6) Training for the proper use of the device must be provided. (7) Physician and patient labeling must include: (i) Summaries of electrical stimulation parameters; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanations of all user-interface components; (iv) Information related to electromagnetic compatibility classification; (v) Instructions on how to clean the device; and (vi) Summaries of clinical performance testing demonstrating safety and effectiveness. [83 FR 52975, Oct. 19, 2018] § 886.5350 Ultrasound cyclodestructive device. (a) Identification. (1) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and (2) Had failures on maximally tolerated drug therapy. (b) Classification. (1) The clinical performance data must demonstrate an appropriate reduction in intraocular pressure in glaucoma patients who: (i) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and (ii) Had failures on maximally tolerated drug therapy, and an evaluation of all adverse events observed during clinical use. (2) Non-clinical performance testing of device features and characteristics must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Ultrasound field characteristics, which must include the total acoustic power radiated by the transducer(s), the spatial distribution of the ultrasound field (including compressional and rarefactional pressure), and spatial-peak, temporal-average intensity; and (ii) Thermal and physical safety characteristics of the device. (3) Simulated use testing to validate that the device performs as intended under anticipated conditions of use, including eye movements and positioning error. (4) Analysis or testing must demonstrate electrical safety in the appropriate use environment. (5) Analysis or testing must demonstrate electromagnetic compatibility (EMC), including wireless coexistence (if applicable) in the appropriate use-environment. (6) Software verification, validation, and hazard analysis must be performed commensurate with the level of concern of the device. (7) The patient-contacting components must be demonstrated to be biocompatible. (8) Performance data must demonstrate sterility of all patient-contacting components labeled as sterile. If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning and reprocessing of these components. (9) Labeling must include: (i) A detailed description of the patient population for which the device is indicated for use, as well as warnings, and precautions regarding potential for device malfunction and use-error pertinent to use of the device. (ii) A detailed summary of the clinical testing, including study outcomes and adverse events. (iii) Information on how the device operates and the typical course of treatment. (iv) Description of all main components of the device including HIFU generator, transducer(s), and controls. The labeling must include the technical specifications of the device including, but not limited to, treatment frequency, total acoustic power delivered by transducer, treatment duration, treatment zone, site targeting, power requirements, weight, and physical dimensions of the device. (v) Where appropriate, validated methods and instructions for reprocessing of any reusable components. (vi) Safe-use conditions for electrical safety and electromagnetic compatibility. [89 FR 43746, May 20, 2024] § 886.5420 Contact lens inserter/remover. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001] § 886.5500 Digital therapy device for amblyopia. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use with labeled compatible visual display devices, including evaluation of all adverse events and device performance to improve measures of visual function. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include characterizations of the technical specifications of the software. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. All visual displays intended for use must undergo compatibility testing to ensure adequate display resolution, luminance, contrast, field of view, image quality, appropriate optical image distance, and verify their compatibility with the software and intended user (such as appropriate interpupillary distance). (4) Labeling must include the following: (i) The minimum hardware and operating system requirements that support the software of the device; (ii) The models of the visual displays validated to be compatible with this device; (iii) The length of treatment and/or retreatment supported by clinical performance testing; and (iv) A summary of the clinical performance testing conducted with the device. (5) Labeling comprehension testing with intended users must be performed. [91 FR 21385, Apr. 22, 2026] § 886.5540 Low-vision magnifier. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.5600 Ptosis crutch. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.5700 Eyelid weight. (a) Identification. (1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid. (b) Classification. (i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed. [79 FR 22015, Apr. 21, 2014] § 886.5800 Ophthalmic bar reader. P>(a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55992, Dec. 4, 2025] § 886.5810 Ophthalmic prism reader. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 886.5820 Closed-circuit television reading system. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001] § 886.5838 Nasolacrimal compression device. (a) Identification. (b) Classification. [81 FR 37500, June 10, 2016] § 886.5840 Magnifying spectacles. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001] § 886.5842 Spectacle frame. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001] § 886.5844 Prescription spectacle lens. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001] § 886.5850 Sunglasses (nonprescription). (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000] § 886.5870 Low-vision telescope. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 886.5900 Electronic vision aid. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001] § 886.5905 Oral electronic vision aid. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability. (3) Software verification, validation, and hazard analysis must be performed. (4) Analysis/testing must validate electromagnetic compatibility. (5) Analysis/testing must validate electrical safety. (6) Analysis/testing must assess and validate wireless coexistence concerns. (7) Any elements of the device that contact the patient must be demonstrated to be biocompatible. (8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use. (9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied ( e.g., [80 FR 57092, Sept. 22, 2015] § 886.5910 Image intensification vision aid. (a) Identification. (b) Classification. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 886.5915 Optical vision aid. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 886.5916 Rigid gas permeable contact lens. (a) Identification. (b) Classification. (2) Class III if the device is intended for extended wear. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994] § 886.5918 Rigid gas permeable contact lens care products. (a) Identification. (b) Classification. [62 FR 30987, June 6, 1997] § 886.5919 Hydrophilic re-coating solution. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity. (2) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the sterility of the device. (4) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device. (7) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses. (8) Labeling must include the following: (i) Instructions on how to correctly use the device, including instructions to use fresh components for each use; (ii) Descriptions of compatible contact lenses; (iii) Descriptions of compatible care solutions; (iv) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and (v) A precaution against use with lenses that have not been demonstrated to be compatible with the device. [89 FR 72323, Sept. 5, 2024] § 886.5925 Soft (hydrophilic) contact lens. (a) Identification. (b) Classification. (2) Class III if the device is intended for extended wear. (c) Date PMA or notice of completion of a PDP is required. [52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994] § 886.5928 Soft (hydrophilic) contact lens care products. (a) Identification. (b) Classification. [62 FR 30988, June 6, 1997] § 886.5933 [Reserved]