QER
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Camera, Ophthalmic, Slit-Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- FDA definition
- An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CLARUS (700) (K243878) | Carl Zeiss Meditec, Inc. | 2025-04-17 |
| CLARUS (K191194) | Carl Zeiss Meditec, Inc. | 2019-06-25 |
| CLARUS (K181444) | Carl Zeiss Meditec, Inc. | 2019-01-10 |
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Every clearance here is in the API, with alerts when new ones post.