510(k) K083478 ยท GEX Powered Laser Surgical Instrument
SMOOTHLIPO
| Applicant | Eleme Medical, Inc., Merrimack NH, US |
| Decision | Substantially Equivalent, Mar 17, 2009 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083478
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.