510(k) Report

Devices descending from K033461

316 later devices reach Candela Vbeam Pulse Dye Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K202503ChromeQuanta System Spa202012—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253765Vanish ProDdc Technologies, Inc.20260—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K241527Pastelle ProWontech Co., Ltd.20253—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—