510(k) Report

Devices descending from K031425

199 later devices reach Gentlewaves Led Photomodulation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203054FlexSysGme German Medical Engineering GmbH20210—
+1K092734E-Light LineEspansione Marketing S.P.A20102—
+1K090762LEDAQuantel Derma GmbH200946—
+1K062991Gentlewaves Consumer Led Photomodulation DeviceLight Bioscience, LLC200822—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K051255Lumiphase-ROpusmed, Inc.2005143—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+2K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+2K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+2K124064Young AgainEspansione Marketing S.P.A20131—
+2K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103415Tanda MaxPharos Life Corporation20110—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+2K090525Loi SystemPalomar Medical Products, Inc.20099—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+3K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+3K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+3K173285Joule SystemSciton, Inc20185—
+3K171702Exciplex308nmClarteis20175—
+3K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+3K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+3K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+4K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+4K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+4K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+4K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233224Epilaser ProEpilady 2000, LLC20240—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K230077LaserMENeauvia North America20232—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222685NIRA Model 2Dermal Photonics Corp20230—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+4K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191086ExciplexClarteis20194—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261473ChromixTermosalud S.L.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—