510(k) K250281 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
DEKA LOTUS
| Applicant | El.En S.P.A., Calenzano, IT |
| Decision | Substantially Equivalent, Feb 26, 2025 |
| Received | Jan 31, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250281
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.