510(k) K261738 ยท GEX Powered Laser Surgical Instrument
Medical Thulium Fiber Laser Systems (UroFiber 150Q)
| Applicant | Rhein Laser Technologies Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Jul 21, 2026 |
| Received | May 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261738
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.