510(k) K212891 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
TempSure System
| Applicant | Cynosure, LLC, Wesford MA, US |
| Decision | Substantially Equivalent, Mar 18, 2022 |
| Received | Sep 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212891
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.