510(k) K261255 ยท MYC Ophthalmoscope, Laser, Scanning
KOWA FM-600
| Applicant | Kowa Company, Ltd. Chofu Factory, Tokyo, JP |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Apr 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261255
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.