510(k) Report

Devices descending from K944090

1,155 later devices reach Candela Alex Lazr Q-Switched Alexandrite Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+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—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+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—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+4K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+4K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, 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—
+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—
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) 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—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+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—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K202172StarWalkerFotona D.O.O.20203—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—