Optina Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250770 | Optina-4C (MHRC-C1N) | September 4, 2025 |
| K231230 | Optina-4C (MHRC-C1N) | December 5, 2023 |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | April 27, 2020 |