ClearanceBrief
510(k) K243701 · GEX Powered Laser Surgical Instrument

AuroLase® System

ApplicantNanospectra Biosciences, Inc., Houston TX, US
DecisionSubstantially Equivalent, Jul 2, 2025
ReceivedNov 29, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243701

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.