510(k) K234104 ยท GEX Powered Laser Surgical Instrument
PICOANDY (Q-Switched Nd:YAG Laser)
| Applicant | Wontech Co., Ltd., 64, Techno 8-Ro, Yuseong-Gu, KR |
| Decision | Substantially Equivalent, Mar 15, 2024 |
| Received | Dec 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234104
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.