510(k) Report

Devices descending from K982816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+7K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+7K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+7K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+7K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+7K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241656Eneka SelectifTermosalud20241—
+7K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+7K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+7K232236EchoQuanta System Spa20230—
+7K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230293TheraFace MaskTherabody, Inc.202316—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+7K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+7K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+7K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+7K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K193266MIINMedico USA, Inc.20210—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192430Epic 980Biolase, Inc.20195—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K170984LG Beauty Led MaskLg Electronics201793—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K163128Epic ProBiolase, Inc.201716—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—