510(k) K241527 ยท GEX Powered Laser Surgical Instrument
Pastelle Pro
| Applicant | Wontech Co., Ltd., 64, Techno 8-Ro, Yuseong-Gu, KR |
| Decision | Substantially Equivalent, Feb 14, 2025 |
| Received | May 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241527
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.