510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K134017GigalaserPowermedic Aps20141—
+4K132976AdvatxAdvalight Aps20141—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110370Q-ClearLight Age, Inc.201135—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K090399Trios SystemViora, Ltd.20090—
+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—
+4K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+4K073000LumaprobeClareblend, Inc.20080—
+4K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+4K080638CLAROClrs Technology Corporation20082—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062369Iridex Oculight TXIridex Corp200673—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+4K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+4K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+4K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+4K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+4K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K043032Dealight IplEuropro, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K040384Mydon CWavelight Laser Technologie AG200451—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+4K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250189AdvaTxAdvalight Aps20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—