510(k) K231894 ยท GEX Powered Laser Surgical Instrument
LED Spectrum therapy instrument
| Applicant | Shenzhenshi Sincoheren S&T Development Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Jun 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231894
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.