Product code MMQ
- Device name
- Topographer, Corneal, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1350
- 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 |
|---|---|---|---|
| K981665 | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE | Bio-Medical Sciences, Inc. | 1998-12-07 |
| K964702 | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 | Euclid Systems Corp. | 1997-05-20 |
| K964891 | ORBSHOT KERATOMETER | Orbtek, Inc. | 1997-03-26 |
| K963762 | CORNEAL TOPOGRAPHER 200 | Eclipse Ventures | 1996-12-23 |
| K950077 | INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) | Par Vision Systems Corp. | 1995-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800019600992 | Auto Ref-Topographer HRKT-1 | Huvitz Co., Ltd. | 2026-01-30 |
| 06973211071623 | Corneal Topographer | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2025-08-18 |
| 06973211071630 | Corneal Topographer | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2025-08-18 |
| 06972039971054 | MOPTIM | Shenzhen CERTAINN Technology Co., Ltd. | 2025-08-15 |
| 08034028770609 | TERA Dry Eye Imager | VISIA IMAGING SRL | 2025-08-06 |
| 09349221000132 | Medmont Meridia Advanced Topographer Vantage | MEDMONT INTERNATIONAL PTY LTD | 2025-07-03 |
| 08800019600770 | Corneal Topographer HTG-1 | Huvitz Co., Ltd. | 2023-06-12 |
| 03662824001846 | TearCheck T | E-SWIN | 2023-03-06 |
| 03662824003048 | TearCheck T | E-SWIN | 2023-03-06 |
| 06945087500002 | Mediworks | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD. | 2022-11-02 |
| 09349221000101 | Medmont Meridia Advanced Topographer Professional | MEDMONT INTERNATIONAL PTY LTD | 2022-09-14 |
| 09349221000118 | Medmont Meridia Advanced Topographer Classic | MEDMONT INTERNATIONAL PTY LTD | 2022-09-14 |
| 04582273603714 | Topographic Modeling System | TOMEY CORPORATION. | 2022-04-01 |
| 08719326059600 | CASSINI | Cassini Technologies B.V. | 2021-03-03 |
| 04582273612099 | TOPOGRAPHIC MODELING SYSTEM | TOMEY CORPORATION. | 2020-10-30 |
| 04582273612129 | TOPOGRAPHIC MODELING SYSTEM | TOMEY CORPORATION. | 2020-10-30 |
| 06945087505175 | Mediworks | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD. | 2020-03-12 |
| 04049584000477 | Keratograph 5M | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2016-09-01 |