510(k) K242293 ยท GEX Powered Laser Surgical Instrument
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
| Applicant | Rhein Laser Technologies Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Nov 19, 2024 |
| Received | Aug 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242293
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.