510(k) Report

Devices descending from K022609

295 later devices reach Surgical Patient Warmer, Model PW820 Jhu through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182604New EraStep UP Skin Laser, LLC201801
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171111SculpsureCynosure, Inc.201710—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+8K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+8K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+8K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+8K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+8K192970SlimusHironic Co., Ltd.20200—
+8K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K171992SculpSureCynosure, Inc.20178—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+9K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+9K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+9K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+9K182741SculpSureCynosure20195—
+10K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+10K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+10K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+10K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+11K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—