510(k) Report

Devices descending from K992757

340 later devices reach Cynosure Apogee-TKS Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K192856MT OneM&T S.R.L.20202—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+5K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+5K160368EVO platformQuanta System Spa201636—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+5K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+5K140527Sensilight MiniEl Global Trade, Ltd.201423—
+5K131870Glide DeviceHome Skinovations, Ltd.201333—
+5K123845MESyneron Beauty, Ltd.2013126—
+5K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+6K261975Braun Aura 7 (6041)CyDen Limited20260—
+6K261977Braun Aura 9 (6042)Cyden Limited20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+6K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K22079410PLTentech Co., Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+6K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+6K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+6K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+6K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+6K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K172181micro IPLEl Global Trade, Ltd.20170—
+6K171227StarWalkerFotona D.O.O.20177—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K170269Hee HR MiniOriental Inspiration Limited201713—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+6K161089sensiLight MiniEl Global Trade, Ltd.20164—
+6K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K141242Glide DeviceHome Skinovations, Ltd.201419—
+6K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+7K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K233237xeo+ FamilyCutera, Inc.20230—
+7K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+7K232274IPL hair removal deviceLumenessa Corp20230—
+7K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+7K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+7K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+7K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+7K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+7K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+7K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+7K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—