HJO
- Product code
- HJO
- Device name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1850
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 108 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253834 | 2026-03-18 | Carl Zeiss Vision GmbH | VISUREF 600 | |
| K231760 | 2024-03-08 | Cylite Pty. , Ltd. | HP-OCT (HP-OCT) |
Official FDA classification page: HJO
Classification and pathway per current FDA publications. Data from openFDA (CC0).