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Title 21 Part 886 → Subpart B → §886.1570

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1570

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1570

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1570


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§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.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]