510(k) K243780 ยท GEX Powered Laser Surgical Instrument
HELIOS 785 Pico (1754V2)
| Applicant | Laseroptek Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Feb 7, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243780
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.