510(k) Report

Devices descending from K020412

106 later devices reach Depilase Twin Lase Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+12K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+12K253344Bellus-QSpeclipse, Inc.20250—
+12K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+12K250165PastelleWontech Co., Ltd.20250—