510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K113151Ifs Laser SystemAbbott Medical Optics, Inc.201219—
+5K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation2011132
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110370Q-ClearLight Age, Inc.201135—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+5K090399Trios SystemViora, Ltd.20090—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+5K073000LumaprobeClareblend, Inc.20080—
+5K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+5K080638CLAROClrs Technology Corporation20082—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K073411LiteduoLight Instruments20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+5K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K060792IllumimedPhotoactif, LLC2006115—
+5K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+5K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+5K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+5K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+5K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+5K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+5K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+5K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+5K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+5K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+5K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+5K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+5K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K043032Dealight IplEuropro, Inc.20050—
+5K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+5K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+5K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+5K033946Lovely SystemMsq (M2), Ltd.2004737—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K040156Ifl Professional System, Model C100Cyden Limited20040—
+5K033933Powerlite 600 EX SystemPreswede AB20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+5K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+5K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+5K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+5K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+5K023881Profile 1064 Laser SystemSciton, Inc2003227—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—