510(k) K192516 ยท GEX Powered Laser Surgical Instrument
Diode Laser 808nm
| Applicant | Beijing Superlaser Technology Co., Ltd., Xihongmen Town, Daxing District, Beijing, CN |
| Decision | Substantially Equivalent, Dec 10, 2019 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192516
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.