510(k) K182365 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
TempSure System
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Aug 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182365
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.