510(k) K240118 ยท GEX Powered Laser Surgical Instrument
Picosecond Nd:YAG Laser System
| Applicant | Smedtrum Medical Technology Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Apr 30, 2024 |
| Received | Jan 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240118
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.