510(k) K180353 ยท GEX Powered Laser Surgical Instrument
Diode laser hair removal device
| Applicant | Zhengzhou PZ Laser Slim Technology Co., Ltd., High-Tech Development Zone, Zhengzhou, CN |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Feb 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180353
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.