510(k) K191518 ยท GEX Powered Laser Surgical Instrument
CO2 Laser System
| Applicant | Shenzhen Gsd Tech Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | Jun 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191518
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.