510(k) K212478 ยท GEX Powered Laser Surgical Instrument
Dermatological diode laser system
| Applicant | Beijing Stelle Laser Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | Aug 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212478
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.