510(k) K250683
K250683 is an FDA 510(k) premarket notification submitted by Optain Health, Inc. for the device "Resolve Fundus Camera". The FDA issued a decision of Substantially Equivalent on April 30, 2025. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2025
- Date Received
- March 6, 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