510(k) K242987 ยท GEX Powered Laser Surgical Instrument
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
| Applicant | Allengers Global Healthcare Private Limited, Derabassi, IN |
| Decision | Substantially Equivalent, Dec 17, 2024 |
| Received | Sep 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242987
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.