ClearanceBrief
510(k) K241407 ยท GEX Powered Laser Surgical Instrument

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

ApplicantBios S.R.L., Vimodrone, IT
DecisionSubstantially Equivalent, Jun 14, 2024
ReceivedMay 17, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K241407

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.