ClearanceBrief
510(k) K113709 ยท GEX Powered Laser Surgical Instrument

MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE

ApplicantBiolitec Medical Devices, Inc., Grandville MA, US
DecisionSubstantially Equivalent, Jan 20, 2012
ReceivedDec 19, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113709

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.