510(k) K091446 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
| Applicant | Palomar Medical Products, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Oct 27, 2009 |
| Received | May 15, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091446
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.