510(k) K122567 ยท GEX Powered Laser Surgical Instrument
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
| Applicant | Sciton, Inc, Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 19, 2013 |
| Received | Aug 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122567
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.