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
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+6K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+6K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+6K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K193201BTL-785FBtl20208—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K180338CellulizeWard Photonics, LLC20182—
+6K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181659Avologi ENEOPremier North America, Inc.20184—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+6K180320dpl IIa PanelLed Technologies, Inc.201814—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K172111Vevazz LEDVevazz, LLC20170—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+6K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+6K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+6K162784Silk'n HSTHome Skinovations, Ltd.20171—
+6K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160821Tria SapphireTria Beauty, Inc.20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160368EVO platformQuanta System Spa201636—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K143554Venus Legacy CXVenus Concept, Ltd.201517—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—