21 CFR 886.4370 - Keratome.

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]

§ 886.4370 - Keratome.

(a) Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

(b) Classification. Class I.

[55 FR 48443, Nov. 20, 1990]

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 886.4370