510(k) K242946 ยท GEX Powered Laser Surgical Instrument
HESTIA (L200-A)
| Applicant | Senbitec Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | Sep 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242946
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.