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
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161503ORIONYerim Engineering Co., Ltd.20161—
+4K153229SuperbiumBios S.R.L.20162—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+4K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+4K140527Sensilight MiniEl Global Trade, Ltd.201423—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+4K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083730IsolazAesthera Corporation20093—
+4K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082298Flash N' GOHome Skinovations, Ltd.2008168—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+4K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K063074Candela 3630 Laser SystemCandela Corp.2006179—
+4K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+4K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—