510(k) Report

Devices descending from K031805

185 later devices reach Blu-U, Model 4170 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100628PlasmaluxlsDaavlin Distributing Co.20100—
+1K1003781 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co.201061
+1K070185Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001Pharos Life Corporation2007139—
+1K062871Lumacare LC-122M Non-Coherent Light SourceLynton Lasers Limited20061—
+1K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+1K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+2K210881M Series Phototherapy EquipmentDaavlin Distributing Co.202121
+2K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company201841
+2K1111724 Series Phototherapy Unit Model 4 SeriesDaavlin Distributing Co.201101
+2K090762LEDAQuantel Derma GmbH200946—
+2K080591Tanda Skincare System, Model: PtscsPharos Life Corporation2008137—
+2K082232Evis MD Plantium BlueAgeless Beauty Corporation20083—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+3K2303823 Series NeoLuxDaavlin Distributing Co.20231—
+3K2125107 Series Phototherapy DeviceDaavlin Distributing Co.202101
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132838Nutra Light BlueNutra Luxe MD, LLC20142—
+3K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K124042Tanda Mini Skincare SystemSyneron Beauty201376—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K121435Silkn BlueHome Skinovations, Ltd.2013125—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K091125Clearwave Phototherapy System for Acne, Model: CWST2Verilux20100—
+3K090744CLAROClrs Technology Corporation20101—
+3K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+3K081570DPL Therapy SystemLed Technologies, LLC200811
+3K070690The Life VesselCottonwood Vessel Corporation20070—
+4K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd.20260—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+4K180320dpl IIa PanelLed Technologies, Inc.201814—
+4K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+4K171702Exciplex308nmClarteis20175—
+4K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162371Pulsaderm ACE-All BlueNutra Luxe MD, LLC20160—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160691Acne Light Therapy WandZuko, Inc.201650—
+4K160821Tria SapphireTria Beauty, Inc.20160—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+4K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+4K150370Nutra Light AdvancedNutra Luxe MD, LLC20150—
+4K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+4K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K241102Luna 4 plusForeo, Inc.20245—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+5K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+5K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+5K210948Omnilux CLEARGlobalmed Technologies202139—
+5K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+5K191086ExciplexClarteis20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K183247dpl FacewareLed Technologies, Inc.201910—
+5K180875Poly RejuvMedtek Skincare, LLC20180—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K1718212 Face / Face EvolutionHeat IN A Click201858—
+5K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—