OPHTHALMIC DEVICES

• Citation: 21 CFR Part 886
• Sections: 143

§ 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..

§ 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).

§ 886.1040 Ocular esthesiometer.

(a) Identification. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

(b) Classification. Class I (general controls). 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.

§ 886.1050 Adaptometer (biophotometer).

(a) Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.

(b) Classification. Class I (general controls). 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.

§ 886.1070 Anomaloscope.

(a) Identification. An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.

(b) Classification. Class I (general controls). 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.

§ 886.1090 Haidinger brush.

(a) Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

(b) Classification. Class I (general controls). 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.

§ 886.1100 Retinal diagnostic software device.

(a) Identification. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.

(b) Classification. Class II (special controls). The special controls for this device are:

(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.

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

§ 886.1140 Ophthalmic chair.

(a) Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

(b) Classification. Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also 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.

§ 886.1150 Visual acuity chart.

(a) Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1160 Color vision plate illuminator.

(a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.

(b) Classification. Class I (general controls). 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.

§ 886.1170 Color vision tester.

(a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1190 Distometer.

(a) Identification. A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1200 Optokinetic drum.

(a) Identification. An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1220 Corneal electrode.

(a) Identification. A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).

(b) Classification. Class II.

§ 886.1250 Euthyscope.

(a) Identification. A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye).

(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-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.

(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.

§ 886.1270 Exophthalmometer.

(a) Identification. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

(b) Classification. Class I (general controls). 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.

§ 886.1290 Fixation device.

(a) Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

(b) Classification. Class I (general controls). 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.

§ 886.1300 Afterimage flasher.

(a) Identification. An afterimage flasher is an AC-powered light that automatically switches on and off to allow performance of an afterimage test in which the patient indicates the positions of afterimages after the light is off. The device is intended to determine harmonious/anomalous retinal correspondence (the condition in which corresponding points on the retina have the same directional value).

(b) Classification. Class II.

§ 886.1320 Fornixscope.

(a) Identification. A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1330 Amsler grid.

(a) Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1340 Haploscope.

(a) Identification. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).

(b) Classification. Class I (general controls). 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.

§ 886.1342 Strabismus detection device.

(a) Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.

(b) Classification. Class II (special controls). The special controls for this device are:

(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.

§ 886.1350 Keratoscope.

(a) Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

(b) Classification. Class I (general controls). The 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.

§ 886.1360 Visual field laser instrument.

(a) Identification. A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.

(b) Classification. Class II.

§ 886.1375 Bagolini lens.

(a) Identification. A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1380 Diagnostic condensing lens.

(a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

(b) Classification. Class II.

§ 886.1390 Flexible diagnostic Fresnel lens.

(a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye).

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1395 Diagnostic Hruby fundus lens.

(a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1400 Maddox lens.

(a) Identification. A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1405 Ophthalmic trial lens set.

(a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

(b) Classification. Class I (general controls). 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.

§ 886.1410 Ophthalmic trial lens clip.

(a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.

(b) Classification. Class I (general controls). 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.

§ 886.1415 Ophthalmic trial lens frame.

(a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1420 Ophthalmic lens gauge.

(a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.

(b) Classification. Class I (general controls). 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.

§ 886.1425 Lens measuring instrument.

(a) Identification. A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

(b) Classification. Class I (general controls). 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.

§ 886.1430 Ophthalmic contact lens radius measuring device.

(a) Identification. An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.

(b) Classification. Class I (general controls). 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.

§ 886.1435 Maxwell spot.

(a) Identification. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.

(b) Classification. Class I (general controls). 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.

§ 886.1450 Corneal radius measuring device.

(a) Identification. A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

(b) Classification. Class I (general controls). 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, only when the device does not include computer software in the unit or topographers.

§ 886.1460 Stereopsis measuring instrument.

(a) Identification. A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1500 Headband mirror.

(a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1510 Eye movement monitor.

(a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

(b) Classification. Class II.

§ 886.1570 Ophthalmoscope.

(a) Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

(b) Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

§ 886.1605 Perimeter.

(a) Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1630 AC-powered photostimulator.

(a) Identification. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

(b) Classification. Class II.

§ 886.1640 Ophthalmic preamplifier.

(a) Identification. An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).

(b) Classification. Class II.

§ 886.1650 Ophthalmic bar prism.

(a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1655 Ophthalmic Fresnel prism.

(a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

(b) Classification. Class I (general controls). 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. The device is also 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.

§ 886.1660 Gonioscopic prism.

(a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

(b) Classification. Class I (general controls). 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.