510(k) K212978 ยท GEX Powered Laser Surgical Instrument
Diode laser therapy system
| Applicant | Beijing Unt Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Sep 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212978
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.