510(k) Report

Devices descending from K982816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202041Opera EvoQuanta System Spa20200—
+8K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+8K191065Venus VivaTMVenus Concept USA, Inc.20200—
+8K193486Epic 980Biolase, Inc.20202—
+8K193426Elite iQCynosure, LLC20201—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+8K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+8K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K172771Epic Pro 940Biolase, Inc.20171—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162512truSculptCutera, Inc.20165—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K160368EVO platformQuanta System Spa201636—
+8K153717Venus Versa SystemVenus Concept, Ltd.20161—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152012EVO platformQuanta System Spa201537—
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K143109XP300BTL Industries, Inc.20150—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K130689Symphony RF GeneratorThermigen, Inc.201311—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K253504Volnewmer™Classys, Inc.20260—
+9K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K240897CellinewVIOL Co., Ltd.20240—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K240313Oligio XWontech Co., Ltd.20241—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—