510(k) K250224 ยท ONE Powered Light Based Non-Laser Surgical Instrument
handLITE (TN19S)
| Applicant | iSMART Developments, Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Apr 18, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250224
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.