510(k) Report

Devices descending from K140122

10 later devices reach Candela Gentlemax Family of Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201111GentleMax Pro PlusCandela Corporation20203—
+1K200110SANDRO DualWontech Co., Ltd.20202—
+1K183452Vbeam Prima Laser SystemCandela Corp.20191—
+1K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+2K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+2K252877SANDRO DualWontech Co., Ltd.20250—
+2K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+2K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+2K223540AvalancheLase FamilyFotona D.O.O.20230—
+2K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—