NKY · Blade, Keratome, Reprocessed
Ophthalmic · 21 CFR 886.4370 · Class 1
Overview
| Product Code | NKY |
|---|---|
| Device Name | Blade, Keratome, Reprocessed |
| Regulation | 21 CFR 886.4370 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.
Cleared Devices (0)
No cleared devices on record.
