510(k) K250770
K250770 is an FDA 510(k) premarket notification submitted by Optina Diagnostics, Inc. for the device "Optina-4C (MHRC-C1N)". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optina Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2025
- Date Received
- March 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type