510(k) K260765 ยท NVK Laser, Dental, Soft Tissue
Gemini NOVA 810+980 Soft Tissue Laser
| Applicant | Azena Medical, LLC, Walnut Creek CA, US |
| Decision | Substantially Equivalent, Mar 10, 2026 |
| Received | Mar 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260765
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.