510(k) K243445 ยท GEX Powered Laser Surgical Instrument
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
| Applicant | Bios S.R.L., Vimodrone, IT |
| Decision | Substantially Equivalent, Dec 30, 2024 |
| Received | Nov 6, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243445
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.