510(k) K201109 ยท GEX Powered Laser Surgical Instrument
CO2 Laser Therapy System
| Applicant | Shanghai Apolo Medical Technology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jul 15, 2020 |
| Received | Apr 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201109
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.