510(k) K180508 ยท GEX Powered Laser Surgical Instrument
JOULE SYSTEM
| Applicant | Sciton, Inc, Palo Alto CA, US |
| Decision | Substantially Equivalent, May 18, 2018 |
| Received | Feb 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180508
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.