510(k) Report

Devices descending from K021180

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+11K250809Stellar M22Lumenis Be, Ltd.20250—
+11K241527Pastelle ProWontech Co., Ltd.20253—
+11K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+11K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+11K222790F65 Laser SystemLumenis Be, Ltd.20233—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K222221Deka HelixEl.En Electronic Engineering Spa20231—
+11K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+11K162781Magma SparkFormatk Systems, Ltd.20160—
+12K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+12K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+12K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+12K242349FoLixLumenis Be, Ltd.20240—
+13K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—