510(k) K250165 ยท GEX Powered Laser Surgical Instrument
Pastelle
| Applicant | Wontech Co., Ltd., Daejeon, KR |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250165
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.