510(k) Report

Devices descending from K081307

169 later devices reach Omnilux Clear-U through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183708Poly ClearMedtek Skincare, LLC201922—
+1K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+1K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+1K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+1K153081Clear Bi-LightMichael Todd, LP201646—
+1K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+1K121435Silkn BlueHome Skinovations, Ltd.2013125—
+1K111286Quasar CalypsoSilver Bay, LLC201276—
+1K090744CLAROClrs Technology Corporation20101—
+2K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+2K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+2K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+2K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+2K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+2K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+2K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+2K180320dpl IIa PanelLed Technologies, Inc.201814—
+2K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+2K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+2K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+2K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+2K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+2K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+2K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+2K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+2K140471Pro X Otc 5La Lumiere, LLC2015107—
+2K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K261473ChromixTermosalud S.L.20260—
+3K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+3K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+3K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+3K241102Luna 4 plusForeo, Inc.20245—
+3K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+3K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+3K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+3K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+3K223147myLEDmaskMyblend20234—
+3K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+3K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+3K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+3K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+3K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+3K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+3K183247dpl FacewareLed Technologies, Inc.201910—
+3K183118dpl SpotLiteLed Technologies, Inc.201922—
+3K180875Poly RejuvMedtek Skincare, LLC20180—
+3K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+3K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+3K1718212 Face / Face EvolutionHeat IN A Click201858—
+3K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+3K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+3K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+3K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+4K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+4K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+4K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+4K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+4K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+4K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+4K252187Aura Glide (FC40)Aura Medical, LLC20250—
+4K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+4K251843Erchonia EVRLErchonia Corporation20250—
+4K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+4K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+4K250125LMNT O2Xplr, Ltd.20250—
+4K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+4K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+4K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+4K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+4K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+4K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+4K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+4K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+4K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+4K230293TheraFace MaskTherabody, Inc.202316—
+4K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+4K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+4K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+4K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+4K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+4K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+4K212155TheraFace LEDTheragun, Inc.202142—
+4K212238TheraFace MicrocurrentTheragun, Inc.20210—
+4K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+4K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+4K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+4K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+4K190443MMSphereGalactic Beauty, LLC201942—
+4K170984LG Beauty Led MaskLg Electronics201793—
+4K160691Acne Light Therapy WandZuko, Inc.201650—
+5K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+5K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—