510(k) Report

Devices descending from K982816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+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—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+7K122966XP200Btl Industries, Ltd.20131—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+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—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., 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—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+8K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+8K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+8K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+8K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+8K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+8K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K250852CoolfaseAsterasys Co., Ltd.20250—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+8K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+8K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K251327XERFLutronic Corporation202501
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+8K242241SunnyShenB Co., Ltd.20250—
+8K243587PureLift GLOWXtreem Pulse, LLC20251—
+8K243330LYMA Laser PROLyma Life, Ltd.20250—
+8K243488Vmat ProTermosalud20250—
+8K240311JETT Medical IICompex, Spol, S.R.O.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+8K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+8K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240248Volnewmer™Classys, Inc.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+8K23299210THERMATentech, Inc.20230—
+8K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K231146AliTightAlic Iotech, LLC20230—
+8K230663DensityJeisys Medical, Inc.20232—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221989The OligioWontech Co., Ltd.20222—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+8K210948Omnilux CLEARGlobalmed Technologies202139—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K200693K2 MobileHulaser, Inc.20202—