510(k) K250018 ยท GEX Powered Laser Surgical Instrument
Medical Diode Laser Systems (THEIA808)
| Applicant | Gigaalaser Company , Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Apr 1, 2025 |
| Received | Jan 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250018
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.