MYD · Keratome, Water Jet
Ophthalmic · 21 CFR 886.4370 · Class 1
Overview
| Product Code | MYD |
|---|---|
| Device Name | Keratome, Water Jet |
| 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 (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991124 | VISIJET HYDROKERATOME, MODEL 50 | Visijet, Inc. | Oct 20, 2000 | SESE |
Top Applicants
- Visijet, Inc. — 1 clearance
