Code of Federal Regulations · Section
§ 886.4390 — Ophthalmic Laser
21 C.F.R. § 886.4390
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(a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351