Total clearances
3
2020-04-27 → 2025-09-04
Name variants in FDA filings: Optina Diagnostics, Inc. / Optina Diagnostics
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| HKI |
Camera, Ophthalmic, Ac-Powered |
Class II |
Ophthalmic |
3 |
2025-09-04 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-09-04 |
K250770 |
Optina-4C (MHRC-C1N) |
HKI |
Class II |
Ophthalmic |
| 2023-12-05 |
K231230 |
Optina-4C (MHRC-C1N) |
HKI |
Class II |
Ophthalmic |
| 2020-04-27 |
K200254 |
Mydriatic Hyperspectral Retinal Camera (MHRC-C1) |
HKI |
Class II |
Ophthalmic |