510(k) K243588 ยท GEX Powered Laser Surgical Instrument
Single Use CO2 Laser Fiber (HAF005001)
| Applicant | Quanta System Spa, Samarate, IT |
| Decision | Substantially Equivalent, Feb 19, 2025 |
| Received | Nov 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243588
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.