510(k) K241791 ยท GEX Powered Laser Surgical Instrument
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
| Applicant | Gigaalaser Company , Ltd., Wu Han, CN |
| Decision | Substantially Equivalent, Mar 19, 2025 |
| Received | Jun 21, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241791
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.