510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+4K042474ARIONWavelight Laser Technologie AG2004114—
+4K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K041262Duralite-GLLaser Scientific20040—
+4K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+4K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+4K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+4K023881Profile 1064 Laser SystemSciton, Inc2003227—
+4K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+4K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+4K030480L600 Hair RemovalA&M Technology20031—
+4K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+4K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+4K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+4K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+4K024064Polaris DSSyneron Medical, Ltd.2003681—
+4K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+4K022607SpectrapulsePrimary Technology, LLC20020—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K020849Apex 800 Laser System, Model Apex 800Iridex Corp2002174—
+4K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229—
+4K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20021—
+4K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+4K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K22079410PLTentech Co., Ltd.20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+5K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192621Medical RFTriworks Group Srl20200—
+5K200616E>EyeCE-Swin20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+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—
+5K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+5K180508Joule SystemSciton, Inc20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K173285Joule SystemSciton, Inc20185—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K172181micro IPLEl Global Trade, Ltd.20170—
+5K171702Exciplex308nmClarteis20175—
+5K172413MT ONEM&T S.R.L.20175—
+5K170970EpilaserEpilady 2000, LLC20172—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170269Hee HR MiniOriental Inspiration Limited201713—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+5K161089sensiLight MiniEl Global Trade, Ltd.20164—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K160368EVO platformQuanta System Spa201636—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—