510(k) Report

Devices descending from K980420

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+9K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+9K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+9K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200693K2 MobileHulaser, Inc.20202—
+9K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+9K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+9K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+9K193486Epic 980Biolase, Inc.20202—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+9K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+9K192224BTL-899Btl20198—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+9K190443MMSphereGalactic Beauty, LLC201942—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K180044SIROLaser BlueDentsply Sirona201812—
+9K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+9K171262TempSureCynosure, Inc.201716—
+9K170984LG Beauty Led MaskLg Electronics201793—
+9K172004truSculptCutera, Inc.20173—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+9K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+9K161981Olive PlusAma Network, Inc.20160—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K161661Thermi RF AccessoriesThermi20163—
+9K160470SculpSureCynosure, Inc.201620—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K160691Acne Light Therapy WandZuko, Inc.201650—
+9K151793InMode RF SystemInmode MD, Ltd.20161—
+9K151629Guardian 1000Quanta System Spa20150—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+9K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+9K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+9K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K132754Neogen PSR SystemEnergist, Ltd.20132—
+9K131839DC 7Dc International, LLC20130—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+9K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K090094Zeltiq SystemZeltiq Aesthetics200932—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+10K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—