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
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+8K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+8K163373PK AIMGyrus Acmi, Inc.20161—
+8K162512truSculptCutera, Inc.20165—
+8K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K152280BioPhotas Celluma3Biophotas, Inc.201649—
+8K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+8K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+8K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+8K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K151629Guardian 1000Quanta System Spa20150—
+8K143554Venus Legacy CXVenus Concept, Ltd.201517—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+8K150035V10 systemViora, Ltd.201531—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K142910Legacy BXVenus Concept USA, Inc.201411—
+8K141904Viora V-TouchViora, Ltd.20140—
+8K140120EPIC 10Biolase, Inc.20141—
+8K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K133837Viora V-TotalViora, Ltd.201433—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K131758Surgen UPollogen, Ltd.20135—
+8K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+8K130459Tria Fan SystemTria Beauty, Inc.20131—
+8K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+8K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+8K122579VelashapeSyneron Medical, Ltd.20124—
+8K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+8K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+8K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+8K101321Ematrix CO2Syneron Medical, Ltd.20102—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K083629SmoothshapesEleme Medical, Inc.200927—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+8K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261473ChromixTermosalud S.L.20260—
+9K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—