Product code HMY
- Device name
- Keratome, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4370
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040297 | ONEUSE- PLUS MICROKERATOME | Moria SA | 2004-03-31 |
| K023092 | BD K-4000 MICROKERATOME SYSTEM | Becton, Dickinson & CO | 2002-10-18 |
| K022637 | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME | Becton, Dickinson & CO | 2002-10-16 |
| K022560 | M2 SINGLE USE MICROKERTOME | Moria SA | 2002-09-27 |
| K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | 2001-03-09 |
| K002191 | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | 2000-10-12 |
| K992687 | MILLENIUM MICROKERATOME, MODEL IMD-001 | Industrial & Medical Design, Inc. | 1999-09-24 |
| K984537 | KERATOME SYSTEM, MODEL K3000 | Insight Technologies Instruments, LLC | 1999-05-14 |
| K981741 | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | 1998-07-24 |
| K974243 | KERATOME SYSTEM | Insight Technologies Instruments, LLC | 1998-01-20 |
| K902857 | VISI-DRAPE OPHTHALMIC DRAPES | Visitec Co. | 1990-07-31 |
| K781412 | OSCILLATING KNIFE AND ACCESSORIES | Codman & Shurtleff, Inc. | 1978-10-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03700483602032 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608478 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608409 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608393 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608379 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608362 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608355 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608348 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608331 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608300 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608294 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608270 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602155 | MORIA | MORIA SA | 2024-05-07 |
| 03700483601974 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602094 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602100 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602124 | MORIA | MORIA SA | 2024-05-07 |
| 03700483603107 | MORIA | MORIA SA | 2024-05-07 |
| 03700483601981 | MORIA | MORIA SA | 2024-05-07 |
| 03700483601998 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602049 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602025 | MORIA | MORIA SA | 2024-05-07 |
| 03700483602117 | MORIA | MORIA SA | 2024-05-07 |
| 03700483603114 | MORIA | MORIA SA | 2024-05-07 |
| 03700483608195 | MORIA | MORIA SA | 2024-05-03 |
| 03700483608201 | MORIA | MORIA SA | 2024-05-03 |
| 03700483608218 | MORIA | MORIA SA | 2024-05-03 |
| 03700483608225 | MORIA | MORIA SA | 2024-05-03 |
| 03700483608232 | MORIA | MORIA SA | 2024-05-03 |
| 03700483608188 | MORIA | MORIA SA | 2024-05-02 |