Keratome.
21 C.F.R. § 886.4370
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
