510(k) K211335 ยท GEX Powered Laser Surgical Instrument
Diode Laser Machine, Model Number: BM-100
| Applicant | Zhengzhou Bestview ST Co., Ltd., Zhengzhou, CN |
| Decision | Substantially Equivalent, Jul 28, 2021 |
| Received | May 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211335
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.