510(k) Report

Devices descending from K030426

563 later devices reach Omnilux Red through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200104OxylightRaja Trading Company, Inc.202024—
+1K150336Photonica ProfessionalWard Photonics, LLC20157—
+1K134017GigalaserPowermedic Aps20141—
+1K120460SmartluxMedmix Co., Ltd.201218—
+1K092734E-Light LineEspansione Marketing S.P.A20102—
+1K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+1K090762LEDAQuantel Derma GmbH200946—
+1K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+1K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+1K073000LumaprobeClareblend, Inc.20080—
+1K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+1K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+1K060792IllumimedPhotoactif, LLC2006115—
+1K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+1K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+1K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+1K051255Lumiphase-ROpusmed, Inc.2005143—
+1K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+1K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+2K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+2K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+2K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+2K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+2K203054FlexSysGme German Medical Engineering GmbH20210—
+2K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+2K191693BC-5Reveallux, Corp20190—
+2K183708Poly ClearMedtek Skincare, LLC201922—
+2K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+2K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+2K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+2K162851eLyx-PROIntelligent Sensory Concept SA20170—
+2K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+2K160880Photonica ProfessionalWard Photonics, LLC20166—
+2K153081Clear Bi-LightMichael Todd, LP201646—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K140386Lumina 24Rogers Sciences, Inc.20150—
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+2K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K124064Young AgainEspansione Marketing S.P.A20131—
+2K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+2K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+2K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+2K121435Silkn BlueHome Skinovations, Ltd.2013125—
+2K122237Biophotas LifelightBiophotas, Inc.201371—
+2K111286Quasar CalypsoSilver Bay, LLC201276—
+2K110301Silk'n FXHome Skinovations, Ltd.201166—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103415Tanda MaxPharos Life Corporation20110—
+2K100628PlasmaluxlsDaavlin Distributing Co.20100—
+2K091467Baby QuasarSilver Bay, LLC20100—
+2K090744CLAROClrs Technology Corporation20101—
+2K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+2K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+2K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+2K090525Loi SystemPalomar Medical Products, Inc.20099—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+3K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+3K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+3K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+3K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+3K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+3K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+3K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+3K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+3K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+3K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+3K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+3K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+3K202955Contour Light CL-100Contour Research, LLC20218—
+3K192275invisa-RED ELITEIR Technology, LLC20201—
+3K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+3K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+3K180338CellulizeWard Photonics, LLC20182—
+3K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K181659Avologi ENEOPremier North America, Inc.20184—
+3K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+3K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—