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
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+7K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K191086ExciplexClarteis20194—
+7K192430Epic 980Biolase, Inc.20195—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+7K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K182173Joule SystemSciton, Inc20195—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt201888—
+7K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+7K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K163415SlimShape SystemSyneron Medical, Ltd.201714—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162512truSculptCutera, Inc.20165—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+7K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150724SculpSureCynosure, Inc.201521—
+7K143559XP1000 RFBTL Industries, Inc.20157—
+7K150230SculpSureCynosure, Inc.201521—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143109XP300BTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+7K141986Elux 810 LaserEquipmed North America, Inc.20150—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K130689Symphony RF GeneratorThermigen, Inc.201311—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—