510(k) K112013 ยท GEX Powered Laser Surgical Instrument
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
| Applicant | Biolitec, Inc., Grandville MA, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Jul 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112013
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.