Product code HMR
- Device name
- Marker, Ocular
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4570
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Refractec, Inc. | 2006-03-03 |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Chiron Vision Corp. | 1994-08-29 |
| K872747 | LASER CENTERING DEVICE | Innomed Corp. | 1987-09-04 |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Myocure, Inc. | 1986-10-20 |
| K861535 | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | CooperVision, Inc. | 1986-05-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04251047934674 | Gerten Cornea Zone Marker | A1 Medical GmbH | 2026-05-29 |
| 00190776420062 | Millennium | Avalign Technologies, Inc. | 2026-04-15 |
| 00190776419387 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776418984 | Millennium | Avalign Technologies, Inc. | 2026-04-13 |
| G22312270490 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2025-11-05 |
| G223M1113100 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2025-06-20 |
| G22314012520 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2025-04-16 |
| G346BP01R0 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2023-01-05 |
| G346ET320 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-23 |
| G346ET310 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-23 |
| G346ET300 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-23 |
| G346ET290 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-23 |
| G346ET220 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET280 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET260 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET250 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET210 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET200 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET180 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET170 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET150 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET120 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET110 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET100 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET050 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-21 |
| G346ET040 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-19 |
| G346ET020 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-19 |
| G346ET010 | Epsilon USA | EPSILON EYE CARE PRIVATE LIMITED | 2022-12-15 |
| 14026704801968 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 35055186205622 | Malosa Medical | Beaver-Visitec International, Inc. | 2022-02-16 |