ClearanceBrief
510(k) K180423 ยท GEX Powered Laser Surgical Instrument

Empower H65

ApplicantQuanta System Spa, Samarate, IT
DecisionSubstantially Equivalent, Mar 15, 2018
ReceivedFeb 16, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K180423

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.