K250683
- 510(k) number
- K250683
- Device name
- Resolve Fundus Camera
- Applicant
- Optain Health, Inc. NY · US
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2025-04-30
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250683.pdf
Official FDA record: K250683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.