21 CFR 886.1630 — Photostimulator, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1630

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).

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HLXPhotostimulator, Ac-Powered2183rd Party
Innolitics

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