Last amended:2016Year:2026Length:35 wordsSubsections:2Official source
Cite as 21 C.F.R. § 886.4370 (2026)
(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]