ClearanceBrief
510(k) K183452 ยท GEX Powered Laser Surgical Instrument

Vbeam Prima Laser System

ApplicantCandela Corp., Wayland MA, US
DecisionSubstantially Equivalent, Feb 1, 2019
ReceivedDec 13, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K183452

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.