510(k) K083900 ยท GEX Powered Laser Surgical Instrument
ERBIUM FRACTIONAL HANDPIECE
| Applicant | Palomar Medical Products, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Feb 27, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083900
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.