510(k) K222862 ยท GEX Powered Laser Surgical Instrument
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
| Applicant | Lotuxs Medtech (Suzhou) Co., Ltd., Suzhou Industrial Park, Suzhou, CN |
| Decision | Substantially Equivalent, Jul 30, 2023 |
| Received | Sep 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222862
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.