510(k) K260974 ยท GEX Powered Laser Surgical Instrument
CO2 Laser Machine (Monica-I,Monica-II)
| Applicant | Nanjing Bestview Laser S&T Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, May 7, 2026 |
| Received | Mar 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260974
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.