StacksVerified U.S. regulatory reference

21 CFR §886.4370

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class I.