510(k) Report

Devices descending from K954013

1,233 later devices reach Trilase 2940 Erbium Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.20148—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+6K134017GigalaserPowermedic Aps20141—
+6K132976AdvatxAdvalight Aps20141—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20145—
+6K131758Surgen UPollogen, Ltd.20135—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+6K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K121091Catalys Precision Laser SystemOptimedica Corporation2012122
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110370Q-ClearLight Age, Inc.201135—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+6K090762LEDAQuantel Derma GmbH200946—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+6K090399Trios SystemViora, Ltd.20090—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+6K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K081408Ellipse MultiflexEllipse A/S20087—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K080638CLAROClrs Technology Corporation20082—
+6K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+6K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+6K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+6K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+6K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+6K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+6K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+6K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+6K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+6K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+6K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K043032Dealight IplEuropro, Inc.20050—
+6K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+6K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+6K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+6K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+6K033946Lovely SystemMsq (M2), Ltd.2004737—
+6K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+6K040156Ifl Professional System, Model C100Cyden Limited20040—
+6K033933Powerlite 600 EX SystemPreswede AB20040—
+6K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+6K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+6K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+6K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+6K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+6K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+6K023881Profile 1064 Laser SystemSciton, Inc2003227—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—