510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+7K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+7K212155TheraFace LEDTheragun, Inc.202142—
+7K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+7K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K212238TheraFace MicrocurrentTheragun, Inc.20210—
+7K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+7K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+7K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K193486Epic 980Biolase, Inc.20202—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+7K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+7K192224BTL-899Btl20198—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190443MMSphereGalactic Beauty, LLC201942—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K171262TempSureCynosure, Inc.201716—
+7K170984LG Beauty Led MaskLg Electronics201793—
+7K172004truSculptCutera, Inc.20173—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+7K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161661Thermi RF AccessoriesThermi20163—
+7K160470SculpSureCynosure, Inc.201620—
+7K152731XP1100 RFBTL Industries, Inc.20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160691Acne Light Therapy WandZuko, Inc.201650—
+7K151793InMode RF SystemInmode MD, Ltd.20161—
+7K151629Guardian 1000Quanta System Spa20150—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K132754Neogen PSR SystemEnergist, Ltd.20132—
+7K131839DC 7Dc International, LLC20130—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+8K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+8K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—