510(k) Report

Devices descending from K043329

202 later devices reach Omnilux Revive and Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162851eLyx-PROIntelligent Sensory Concept SA20170—
+1K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+1K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+2K183708Poly ClearMedtek Skincare, LLC201922—
+2K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+2K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+2K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+2K153081Clear Bi-LightMichael Todd, LP201646—
+2K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+2K121435Silkn BlueHome Skinovations, Ltd.2013125—
+2K111286Quasar CalypsoSilver Bay, LLC201276—
+2K090744CLAROClrs Technology Corporation20101—
+2K090762LEDAQuantel Derma GmbH200946—
+3K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+3K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+3K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+3K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+3K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+3K200104OxylightRaja Trading Company, Inc.202024—
+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—
+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—
+3K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+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—
+3K140471Pro X Otc 5La Lumiere, LLC2015107—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+4K261473ChromixTermosalud S.L.20260—
+4K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+4K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+4K241102Luna 4 plusForeo, Inc.20245—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+4K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+4K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+4K223147myLEDmaskMyblend20234—
+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—
+4K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+4K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+4K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+4K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+4K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K183247dpl FacewareLed Technologies, Inc.201910—
+4K183118dpl SpotLiteLed Technologies, Inc.201922—
+4K180875Poly RejuvMedtek Skincare, LLC20180—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+4K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+4K1718212 Face / Face EvolutionHeat IN A Click201858—
+4K171702Exciplex308nmClarteis20175—
+4K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+4K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+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—
+5K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, 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—
+5K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+5K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., 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—
+5K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+5K252187Aura Glide (FC40)Aura Medical, LLC20250—
+5K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+5K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+5K250125LMNT O2Xplr, Ltd.20250—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+5K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+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—