510(k) K192528 ยท GEX Powered Laser Surgical Instrument
CO2 Laser Therapy System
| Applicant | Shangdong Huamei Technology Co., Ltd., Weifang, CN |
| Decision | Substantially Equivalent, Dec 3, 2019 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192528
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.