510(k) K254197 ยท GEX Powered Laser Surgical Instrument
Picasso Pro Diode Laser (002-00460)
| Applicant | CAO Group, Inc., West Jordan UT, US |
| Decision | Substantially Equivalent, Mar 11, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254197
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.