510(k) Report

Devices descending from K982636

322 later devices reach Patient Warmer- Model PW810 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K22079410PLTentech Co., Ltd.20220—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+8K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182604New EraStep UP Skin Laser, LLC201801
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K171111SculpsureCynosure, Inc.201710—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+9K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+9K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+9K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+9K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+9K192970SlimusHironic Co., Ltd.20200—
+9K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K171992SculpSureCynosure, Inc.20178—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—