21 CFR 886.1300 — Flasher, Afterimage, Ophthalmic

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1300

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).

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
NJGFlasher, Afterimage, Ophthalmic203rd Party
Innolitics

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