510(k) Report

Devices descending from K050370

239 later devices reach Palomar Luxir Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K200693K2 MobileHulaser, Inc.20202—
+5K200616E>EyeCE-Swin20200—
+5K200786Venus EpileveVenus Concept USA, Inc.20200—
+5K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193656SkyPulseFotona D.O.O.202011—
+5K193486Epic 980Biolase, Inc.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+5K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K180406Ellipse YdunEllipse A/S20180—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+5K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+5K161981Olive PlusAma Network, Inc.20160—
+5K160470SculpSureCynosure, Inc.201620—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+5K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K22079410PLTentech Co., Ltd.20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+6K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+6K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+6K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+6K182604New EraStep UP Skin Laser, LLC201801
+6K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K171111SculpsureCynosure, Inc.201710—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+7K260138LUNE PureHygieneEnamel Pure20260—
+7K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+7K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—