ClearanceBrief
510(k) K180044 ยท GEX Powered Laser Surgical Instrument

SIROLaser Blue

ApplicantDentsply Sirona, York PA, US
DecisionSubstantially Equivalent, Mar 8, 2018
ReceivedJan 8, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180044

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.