510(k) Report

Devices descending from K043317

171 later devices reach Omnilux Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162851eLyx-PROIntelligent Sensory Concept SA20170—
+1K120460SmartluxMedmix Co., Ltd.201218—
+1K113668Healite II SystemLutronic Corporation20120—
+1K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+1K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+1K073000LumaprobeClareblend, Inc.20080—
+1K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+1K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+1K060792IllumimedPhotoactif, LLC2006115—
+1K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+2K203054FlexSysGme German Medical Engineering GmbH20210—
+2K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+2K191693BC-5Reveallux, Corp20190—
+2K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+2K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+2K152280BioPhotas Celluma3Biophotas, Inc.201649—
+2K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+2K124064Young AgainEspansione Marketing S.P.A20131—
+2K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+2K122237Biophotas LifelightBiophotas, Inc.201371—
+2K111286Quasar CalypsoSilver Bay, LLC201276—
+2K110301Silk'n FXHome Skinovations, Ltd.201166—
+2K100628PlasmaluxlsDaavlin Distributing Co.20100—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K091467Baby QuasarSilver Bay, LLC20100—
+2K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+2K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+2K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+3K221083Smartlux MiniMedmix Co., Ltd.20222—
+3K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+3K202955Contour Light CL-100Contour Research, LLC20218—
+3K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+3K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+3K181659Avologi ENEOPremier North America, Inc.20184—
+3K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+3K162784Silk'n HSTHome Skinovations, Ltd.20171—
+3K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+3K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+3K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+3K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+3K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+3K131113Biophotas CellumaBiophotas, Inc.201455—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+4K243854Contour Light (CL-100)Contour Research, LLC20261—
+4K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+4K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+4K250125LMNT O2Xplr, Ltd.20250—
+4K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+4K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+4K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+4K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K230077LaserMENeauvia North America20232—
+4K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+4K222685NIRA Model 2Dermal Photonics Corp20230—
+4K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+4K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+4K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+4K180875Poly RejuvMedtek Skincare, LLC20180—
+4K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+4K1718212 Face / Face EvolutionHeat IN A Click201858—
+4K170068Softcure 96Wellray Medical Laser, Inc.20170—
+4K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+4K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+4K141868Tria FanpTria Beauty, Inc.20140—
+5K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K261473ChromixTermosalud S.L.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+5K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+5K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+5K252187Aura Glide (FC40)Aura Medical, LLC20250—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—