510(k) K221597 ยท GEX Powered Laser Surgical Instrument
CO2 Laser System
| Applicant | Smedtrum Medical Technology Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Sep 15, 2022 |
| Received | Jun 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221597
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.