510(k) K230580 ยท GEX Powered Laser Surgical Instrument
Diode Laser System
| Applicant | Smedtrum Medical Technology Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Mar 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230580
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.