Title 21 Part 886 → Subpart B → §886.1250

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1250

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1250

e-CFR data is current as of October 10, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1250

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§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. Class I 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. Class II for the AC-powered device.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]

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