510(k) Report

Devices descending from K955531

1,329 later devices reach Arthrocare Bipolar Loop Electrode System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+7K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K072394Portrait Stand-OffRhytec Incorporated2007104—
+7K071872VelashapeSyneron Medical, Ltd.2007127—
+7K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+7K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+7K061603SmoothshapesBiocellulase, Inc.200648—
+7K053611SmoothshapesBicellulase, Inc.200695—
+7K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+7K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K041969Aurora DSSyneron Medical, Ltd.2004302—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K262364Ellian Enigma RF DeviceEllian Corp20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+8K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K250189AdvaTxAdvalight Aps20250—
+8K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+8K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+8K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+8K243488Vmat ProTermosalud20250—
+8K240311JETT Medical IICompex, Spol, S.R.O.20250—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K233344Regenalase Laser SystemIpg Medical20240—
+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—
+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—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K231054V-LaserWontech Co., Ltd.20231—
+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—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+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—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+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
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—