QER
- Product code
- QER
- Device name
- Camera, Ophthalmic, Slit-Scanning
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1120
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243878 | 2025-04-17 | Carl Zeiss Meditec, Inc. | CLARUS (700) |
Official FDA classification page: QER
Classification and pathway per current FDA publications. Data from openFDA (CC0).