510(k) Report

Devices descending from K083733

39 later devices reach Lume 2 System, Model GA0005000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+2K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+2K153566Magma SystemFormatk Systems, Ltd.20162—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K200616E>EyeCE-Swin20200—
+3K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+3K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+3K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+3K162781Magma SparkFormatk Systems, Ltd.20160—
+4K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K250809Stellar M22Lumenis Be, Ltd.20250—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K222790F65 Laser SystemLumenis Be, Ltd.20233—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K242349FoLixLumenis Be, Ltd.20240—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—