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
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+8K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+8K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+8K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K22079410PLTentech Co., Ltd.20220—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K213612Sylfirm XVIOL Co., Ltd.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K213594Echolaser X4Elesta S.P.A20221—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K211562Virtue RFShenB Co., Ltd.20212—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200616E>EyeCE-Swin20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K192728AgnesAgnes Medical Co., Ltd.20196—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+8K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K182365TempSure SystemCynosure, Inc.201815—
+8K180338CellulizeWard Photonics, LLC20182—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K180508Joule SystemSciton, Inc20183—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K172413MT ONEM&T S.R.L.20175—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K171227StarWalkerFotona D.O.O.20177—