510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+5K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K233237xeo+ FamilyCutera, Inc.20230—
+5K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+5K232236EchoQuanta System Spa20230—
+5K232274IPL hair removal deviceLumenessa Corp20230—
+5K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+5K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+5K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+5K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+5K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+5K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+5K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+5K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+5K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K192621Medical RFTriworks Group Srl20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd.201966—
+5K191693BC-5Reveallux, Corp20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+5K183217IPL Hair Removal DeviceTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.20193—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd.201836—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+5K180383Light based hair removal deviceShenzhen Gsd Tech Co., Ltd.20181—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K180016Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd.201825—
+5K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K171227StarWalkerFotona D.O.O.20177—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—