510(k) K251077 ยท GEX Powered Laser Surgical Instrument
JOULE 1064nm System and Accessories
| Applicant | Sciton, Inc, Palo Alto CA, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Apr 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251077
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.