510(k) K101506 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
| Applicant | Palomar Medical Technologies, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Sep 1, 2010 |
| Received | Jun 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101506
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.