510(k) Report

Devices descending from K030883

524 later devices reach Omnilux Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+1K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+1K120460SmartluxMedmix Co., Ltd.201218—
+1K092734E-Light LineEspansione Marketing S.P.A20102—
+1K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+1K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+1K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+1K073000LumaprobeClareblend, Inc.20080—
+1K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+1K060792IllumimedPhotoactif, LLC2006115—
+1K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+1K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+1K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+1K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+1K041103AcneliftInner Act, LLC2004116—
+1K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+2K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+2K203054FlexSysGme German Medical Engineering GmbH20210—
+2K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+2K191693BC-5Reveallux, Corp20190—
+2K183708Poly ClearMedtek Skincare, LLC201922—
+2K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+2K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+2K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+2K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+2K152280BioPhotas Celluma3Biophotas, Inc.201649—
+2K153081Clear Bi-LightMichael Todd, LP201646—
+2K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+2K124064Young AgainEspansione Marketing S.P.A20131—
+2K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+2K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+2K121435Silkn BlueHome Skinovations, Ltd.2013125—
+2K122237Biophotas LifelightBiophotas, Inc.201371—
+2K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+2K111286Quasar CalypsoSilver Bay, LLC201276—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K100628PlasmaluxlsDaavlin Distributing Co.20100—
+2K090744CLAROClrs Technology Corporation20101—
+2K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+2K090762LEDAQuantel Derma GmbH200946—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+3K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221083Smartlux MiniMedmix Co., Ltd.20222—
+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—
+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—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+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—
+3K180320dpl IIa PanelLed Technologies, Inc.201814—
+3K173285Joule SystemSciton, Inc20185—
+3K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+3K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+3K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+3K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+3K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+3K160821Tria SapphireTria Beauty, Inc.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+3K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+3K141237Harmony LiteAlma, Inc.20154—
+3K140471Pro X Otc 5La Lumiere, LLC2015107—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K131113Biophotas CellumaBiophotas, Inc.201455—
+3K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—