510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+10K190443MMSphereGalactic Beauty, LLC201942—
+10K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+10K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+10K173503Pollogen Legend SystemPollogen, Ltd.20183—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K173199PicoSure WorkstationCynosure, Inc.20189—
+10K172771Epic Pro 940Biolase, Inc.20171—
+10K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+10K170984LG Beauty Led MaskLg Electronics201793—
+10K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+10K172096FraxisIlooda Co,., Ltd.20172—
+10K170325Secret RFIlooda Co,., Ltd.201710—
+10K162755PicocareWontech Co., Ltd.20179—
+10K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163415SlimShape SystemSyneron Medical, Ltd.201714—
+10K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+10K162512truSculptCutera, Inc.20165—
+10K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+10K160691Acne Light Therapy WandZuko, Inc.201650—
+10K152856Helios IIILaseroptek Co., Ltd.20165—
+10K160480PicoSure WorkstationCynosure, Inc.201620—
+10K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+10K153566Magma SystemFormatk Systems, Ltd.20162—
+10K153717Venus Versa SystemVenus Concept, Ltd.20161—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+10K152611V20 systemViora, Ltd.20164—
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K143559XP1000 RFBTL Industries, Inc.20157—
+10K150035V10 systemViora, Ltd.201531—
+10K150326PicoWay Laser SystemCandela Corporation201568—
+10K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+10K143109XP300BTL Industries, Inc.20150—
+10K143105Picosure WorkstationCynosure, Inc.201549—
+10K142372Pico Way Laser SystemCandela Corpation201470—
+10K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+10K140719Picosure WorkstationCynosure, Inc.201450—
+10K130689Symphony RF GeneratorThermigen, Inc.201311—
+10K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+10K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+11K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+11K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+11K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+11K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+11K253504Volnewmer™Classys, Inc.20260—
+11K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+11K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+11K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+11K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+11K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+11K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+11K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+11K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+11K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+11K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+11K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+11K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+11K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+11K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+11K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+11K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+11K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+11K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+11K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+11K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+11K243587PureLift GLOWXtreem Pulse, LLC20251—
+11K243330LYMA Laser PROLyma Life, Ltd.20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+11K243139Reverso Pro SystemIndiba S. A. U.20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+11K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+11K240897CellinewVIOL Co., Ltd.20240—
+11K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+11K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+11K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+11K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+11K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+11K233473Deka LotusEl.En S.P.A.20241—
+11K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+11K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+11K234085LUNE™ PureHygieneEnamel Pure20241—
+11K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+11K240313Oligio XWontech Co., Ltd.20241—