510(k) K102755 ยท GEX Powered Laser Surgical Instrument
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
| Applicant | Biolitec, Inc., East Longmeadow MA, US |
| Decision | Substantially Equivalent, Dec 16, 2010 |
| Received | Sep 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102755
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.