510(k) K252877 ยท GEX Powered Laser Surgical Instrument
SANDRO Dual
| Applicant | Wontech Co., Ltd., 64, Techno 8-Ro, Yuseong-Gu, KR |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Sep 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252877
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.