HMY · Keratome, Battery-Powered
Ophthalmic · 21 CFR 886.4370 · Class 1
Overview
| Product Code | HMY |
|---|---|
| Device Name | Keratome, Battery-Powered |
| 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 (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040297 | ONEUSE- PLUS MICROKERATOME | Moria SA | Mar 31, 2004 | SESE |
| K023092 | BD K-4000 MICROKERATOME SYSTEM | Becton, Dickinson & CO | Oct 18, 2002 | SESE |
| K022637 | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME | Becton, Dickinson & CO | Oct 16, 2002 | SESE |
| K022560 | M2 SINGLE USE MICROKERTOME | Moria SA | Sep 27, 2002 | SESE |
| K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | Mar 9, 2001 | SESE |
| K002191 | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | Oct 12, 2000 | SESE |
| K992687 | MILLENIUM MICROKERATOME, MODEL IMD-001 | Industrial & Medical Design, Inc. | Sep 24, 1999 | SESE |
| K984537 | KERATOME SYSTEM, MODEL K3000 | Insight Technologies Instruments, LLC | May 14, 1999 | SESE |
| K981741 | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | Jul 24, 1998 | SESE |
| K974243 | KERATOME SYSTEM | Insight Technologies Instruments, LLC | Jan 20, 1998 | SESE |
| K902857 | VISI-DRAPE OPHTHALMIC DRAPES | Visitec Co. | Jul 31, 1990 | SESE |
| K781412 | OSCILLATING KNIFE AND ACCESSORIES | Codman & Shurtleff, Inc. | Oct 11, 1978 | SESE |
Top Applicants
- Moria, Inc. — 3 clearances
- Moria SA — 2 clearances
- Insight Technologies Instruments, LLC — 2 clearances
- Becton, Dickinson & CO — 2 clearances
- Visitec Co. — 1 clearance
