510(k) Report

Devices descending from K041242

229 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K142860Lumenis M22 SystemLumenis, Ltd.2015381
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K242349FoLixLumenis Be, Ltd.20240—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—