21 CFR 886.4370 — Keratome, Battery-Powered
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4370
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.
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HMY | Keratome, Battery-Powered | 1 | 12 | 3rd Party |
| HNO | Keratome, Ac-Powered | 1 | 83 | 3rd Party |
| MYD | Keratome, Water Jet | 1 | 1 | 3rd Party |
| NKY | Blade, Keratome, Reprocessed | 1 | 0 | 3rd Party |
