510(k) Report

Devices descending from K003092

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K191086ExciplexClarteis20194—
+7K192430Epic 980Biolase, Inc.20195—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K163128Epic ProBiolase, Inc.201716—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+7K122966XP200Btl Industries, Ltd.20131—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+7K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+7K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+7K081408Ellipse MultiflexEllipse A/S20087—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K250852CoolfaseAsterasys Co., Ltd.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+8K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+8K251327XERFLutronic Corporation202501
+8K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—