510(k) Report

Devices descending from K962321

1,327 later devices reach Arthocare Arthroscopic Electrosurgery System Model 970 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+9K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K191086ExciplexClarteis20194—
+9K192224BTL-899Btl20198—
+9K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K190678TempSureCynosure, Inc.201914—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+9K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K183247dpl FacewareLed Technologies, Inc.201910—
+9K183118dpl SpotLiteLed Technologies, Inc.201922—
+9K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K180875Poly RejuvMedtek Skincare, LLC20180—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+9K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+9K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+9K1718212 Face / Face EvolutionHeat IN A Click201858—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+9K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+9K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+9K171262TempSureCynosure, Inc.201716—
+9K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+9K172004truSculptCutera, Inc.20173—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K170068Softcure 96Wellray Medical Laser, Inc.20170—
+9K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+9K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+9K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+9K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+9K152737Lite TouchFocus Medical, LLC20160—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K152611V20 systemViora, Ltd.20164—
+9K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+9K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+9K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+9K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+9K151655CO2RE SystemSyneron Medical, Ltd.20151—
+9K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+9K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+9K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+9K141868Tria FanpTria Beauty, Inc.20140—
+9K142093V20 SystemViora, Ltd.201432—
+9K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+9K133364Picosure WorkstationCynosure, Inc.201451—
+9K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+9K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+9K132754Neogen PSR SystemEnergist, Ltd.20132—
+9K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+9K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+9K131839DC 7Dc International, LLC20130—
+9K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+9K130465EPIC 10SBiolase Technology, Inc.20130—