510(k) Report

Devices descending from K201111

3 later devices reach GentleMax Pro Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252877SANDRO DualWontech Co., Ltd.20250—
+1K223540AvalancheLase FamilyFotona D.O.O.20230—
+1K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—