510(k) K120231 ยท GEX Powered Laser Surgical Instrument
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
| Applicant | Biolitec Medical Devices, Inc., Grandville MA, US |
| Decision | Substantially Equivalent, Apr 24, 2012 |
| Received | Jan 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120231
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.