510(k) Report

Devices descending from K053047

205 later devices reach Fraxel SR Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K223680Eneka ProTermosalud20230—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K171227StarWalkerFotona D.O.O.20177—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K152714Quanta ForteQuanta System Spa201513—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K241656Eneka SelectifTermosalud20241—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K234057NirvanaEl.En S.P.A.20240—
+9K233024Alma HarmonyAlma Lasers, Inc.20241—
+9K232236EchoQuanta System Spa20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K22079410PLTentech Co., Ltd.20220—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K221571InMode Multi-systemInMode, Ltd.20222—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K202288FinebeamSNJ Co., Ltd.20212—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K202172StarWalkerFotona D.O.O.20203—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K172413MT ONEM&T S.R.L.20175—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+10K252723Dynamis Pro FamilyFotona D.O.O.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—