510(k) Report

Devices descending from K003092

736 later devices reach Modification to Vnus Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171227StarWalkerFotona D.O.O.20177—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153229SuperbiumBios S.R.L.20162—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K141237Harmony LiteAlma, Inc.20154—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K22079410PLTentech Co., Ltd.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192621Medical RFTriworks Group Srl20200—
+6K200616E>EyeCE-Swin20200—