510(k) Report

Devices descending from K030883

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+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—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology 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—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+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—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, 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—
+5K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+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—
+5K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+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—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+5K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+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—
+5K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+5K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+5K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+5K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+5K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+5K230293TheraFace MaskTherabody, Inc.202316—
+5K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+5K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+5K223680Eneka ProTermosalud20230—
+5K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K212155TheraFace LEDTheragun, Inc.202142—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212238TheraFace MicrocurrentTheragun, Inc.20210—
+5K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K191086ExciplexClarteis20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190443MMSphereGalactic Beauty, LLC201942—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K170984LG Beauty Led MaskLg Electronics201793—
+5K171227StarWalkerFotona D.O.O.20177—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160691Acne Light Therapy WandZuko, Inc.201650—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—