510(k) Report

Devices descending from K032229

198 later devices reach Quantum Warp 10 Light Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110558CS1000 Light Therapy DeviceGenesis Health Light Corporation20120—
+1K120582HeatluxHome Skinovations, Ltd.20123—
+1K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC20121—
+1K113231WARP10,WARP75Quantum Devices, Inc.20120—
+1K101716HVR Pain Relief DeviceH.V.R., Inc.20115—
+1K090008Tanda Restore, Model PtscsPharos Life Corporation20096—
+1K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC200915—
+1K070690The Life VesselCottonwood Vessel Corporation20070—
+1K072048Lumacare Model LC-122M Non-Coherent Light Source and Model Lum-P Fibre Optic ProbeLynton Lasers Limited20070—
+1K062635MODEL 2200Clarimedex, Inc.20060—
+1K043055Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc.200519—
+1K051046Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC200503
+1K043317Omnilux PlusPhoto Therapeutics Limited2005171—
+1K042813Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC200522—
+1K042532Biocare Systems Premir 818Biocare Systems, Inc.20048—
+2K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+2K162851eLyx-PROIntelligent Sensory Concept SA20170—
+2K162763Vevazz LED Heat LampVevazz, LLC20170—
+2K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+2K150716Varaya SportVaraya Photoceuticals, LLC20150—
+2K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+2K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+2K150175HeatLux Pro IHome Skinovations, Ltd.20151—
+2K120460SmartluxMedmix Co., Ltd.201218—
+2K113668Healite II SystemLutronic Corporation20120—
+2K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+2K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+2K073681Nanobeam 940, Model 940-900-02Davaray, Inc.20080—
+2K073000LumaprobeClareblend, Inc.20080—
+2K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+2K080689Spectra Therapy System A1000 Laser DevicePremier Dynamics, Inc.20080—
+2K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+2K060792IllumimedPhotoactif, LLC2006115—
+2K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc.200617—
+2K051816Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc.200531
+2K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+3K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+3K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+3K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+3K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+3K203054FlexSysGme German Medical Engineering GmbH20210—
+3K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+3K191693BC-5Reveallux, Corp20190—
+3K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+3K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+3K170068Softcure 96Wellray Medical Laser, Inc.20170—
+3K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+3K152280BioPhotas Celluma3Biophotas, Inc.201649—
+3K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+3K142025Neurolumen PN-1000Neurolumen, LLC20150—
+3K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K122237Biophotas LifelightBiophotas, Inc.201371—
+3K111286Quasar CalypsoSilver Bay, LLC201276—
+3K110301Silk'n FXHome Skinovations, Ltd.201166—
+3K100628PlasmaluxlsDaavlin Distributing Co.20100—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K091467Baby QuasarSilver Bay, LLC20100—
+3K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+3K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K081570DPL Therapy SystemLed Technologies, LLC200811
+4K261473ChromixTermosalud S.L.20260—
+4K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+4K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+4K221083Smartlux MiniMedmix Co., Ltd.20222—
+4K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+4K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+4K181659Avologi ENEOPremier North America, Inc.20184—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K162784Silk'n HSTHome Skinovations, Ltd.20171—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+4K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+4K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+5K250125LMNT O2Xplr, Ltd.20250—
+5K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—