510(k) K100726 ยท GEX Powered Laser Surgical Instrument
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
| Applicant | Biolitec, Inc., Grandville MA, US |
| Decision | Substantially Equivalent, Sep 15, 2010 |
| Received | Mar 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100726
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.