Medical Device Manufacturer · CA , Montreal

Optina Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optina Diagnostics, Inc. Ophthalmic ✕
2 devices
1-2 of 2
Cleared CT Sep 04, 2025
Optina-4C (MHRC-C1N)
K250770 · HKI
Ophthalmic · 175d
Cleared Dec 05, 2023
Optina-4C (MHRC-C1N)
K231230 · HKI
Ophthalmic · 221d
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