510(k) Report

Devices descending from K982816

973 later devices reach Vnus Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K153229SuperbiumBios S.R.L.20162—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K140386Lumina 24Rogers Sciences, Inc.20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121435Silkn BlueHome Skinovations, Ltd.2013125—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110301Silk'n FXHome Skinovations, Ltd.201166—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K103415Tanda MaxPharos Life Corporation20110—
+4K100628PlasmaluxlsDaavlin Distributing Co.20100—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K091467Baby QuasarSilver Bay, LLC20100—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090744CLAROClrs Technology Corporation20101—
+4K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+4K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+4K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+4K031671Polaris WRSyneron Medical, Ltd.2003678—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K231948MediyagMedicreations, LLC20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K234057NirvanaEl.En S.P.A.20240—