510(k) K250183 ยท GEX Powered Laser Surgical Instrument
CO2 Laser System (CO2 Laser SST-L23)
| Applicant | Zhuozhou Summer Star Technologies Co., Ltd., Zhuozhou, CN |
| Decision | Substantially Equivalent, Apr 24, 2025 |
| Received | Jan 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250183
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.