510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+8K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+8K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+8K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K210084SilkroHironic Co., Ltd.20223—
+8K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+8K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+8K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+8K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+8K212082PicoreBio-Med USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+8K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+8K193486Epic 980Biolase, Inc.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+8K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+8K192224BTL-899Btl20198—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K171262TempSureCynosure, Inc.201716—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K172004truSculptCutera, Inc.20173—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+8K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+8K161981Olive PlusAma Network, Inc.20160—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161661Thermi RF AccessoriesThermi20163—
+8K160470SculpSureCynosure, Inc.201620—
+8K152731XP1100 RFBTL Industries, Inc.20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160691Acne Light Therapy WandZuko, Inc.201650—
+8K151793InMode RF SystemInmode MD, Ltd.20161—
+8K151629Guardian 1000Quanta System Spa20150—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+8K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+8K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131839DC 7Dc International, LLC20130—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K130465EPIC 10SBiolase Technology, Inc.20130—