21 CFR 886.4390 - Ophthalmic laser.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart E [§ 886.4070 - § 886.4855]

§ 886.4390 - Ophthalmic laser.

(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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

cite as: 21 CFR 886.4390