510(k) Report

Devices descending from K964849

1,322 later devices reach Arthrocare Dermatologic Electrosurgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+10K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+10K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+10K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+10K243587PureLift GLOWXtreem Pulse, LLC20251—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K243330LYMA Laser PROLyma Life, Ltd.20250—
+10K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+10K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+10K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+10K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+10K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+10K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+10K223110truSculpt iDCutera, Inc.20221—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K212663Helios IV 785Laseroptek Co., Ltd.20223—
+10K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K212891TempSure SystemCynosure, LLC20221—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+10K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+10K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+10K211107BTL-899 FPBTL Industries, Inc.20213—
+10K210948Omnilux CLEARGlobalmed Technologies202139—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K210226PicoSure WorkstationCynosure, LLC20213—
+10K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202041Opera EvoQuanta System Spa20200—
+10K193486Epic 980Biolase, Inc.20202—
+10K193426Elite iQCynosure, LLC20201—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+10K191685PicoWay Laser SystemCandela Corporation201920—
+10K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+10K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+10K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+10K182997enlighten III Laser SystemCutera, Inc.20180—
+10K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+10K181272Picocare FamilyWontech Co., Ltd.20188—
+10K173700PICOPLUS Laser SystemLutronic Corporation20187—
+10K180406Ellipse YdunEllipse A/S20180—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K172771Epic Pro 940Biolase, Inc.20171—
+10K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+10K170709CURVE Laser SystemYolo Medical, Inc.20170—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+10K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160470SculpSureCynosure, Inc.201620—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K160368EVO platformQuanta System Spa201636—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152012EVO platformQuanta System Spa201537—
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K261570Picosure WorkstationCynosure, LLC20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+11K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+11K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—