510(k) Report

Devices descending from K980420

1,494 later devices reach Lightsheer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213261EpilMENeauvia North America20220—
+7K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+7K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+7K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+7K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K203510IPL Hair removalShenzhen Weikai Technology Co.,Ltd20211—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K193201BTL-785FBtl20208—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K193426Elite iQCynosure, LLC20201—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+7K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd.201966—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+7K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K183217IPL Hair Removal DeviceTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.20193—
+7K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K180338CellulizeWard Photonics, LLC20182—
+7K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd.201836—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K180383Light based hair removal deviceShenzhen Gsd Tech Co., Ltd.20181—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K180016Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd.201825—
+7K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.20180—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172111Vevazz LEDVevazz, LLC20170—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K171702Exciplex308nmClarteis20175—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+7K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K160821Tria SapphireTria Beauty, Inc.20160—
+7K160368EVO platformQuanta System Spa201636—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—