K250770
- 510(k) number
- K250770
- Device name
- Optina-4C (MHRC-C1N)
- Applicant
- Optina Diagnostics, Inc. CA
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2025-09-04
- Date received
- 2025-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250770.pdf
Official FDA record: K250770
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.