510(k) K191349 ยท GEX Powered Laser Surgical Instrument
980nm Diode Laser Therapy Device
| Applicant | Shanghai Apolo Medical Technology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | May 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191349
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.