510(k) K101916 ยท GEX Powered Laser Surgical Instrument
JOULE MULTI-PLATFORM SYSTEM
| Applicant | Sciton, Inc, Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 18, 2011 |
| Received | Jul 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101916
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.