510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193266MIINMedico USA, Inc.20210—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+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—
+7K191086ExciplexClarteis20194—
+7K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K183566CLARITY II Laser SystemLutronic Corporation201911
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K182173Joule SystemSciton, Inc20195—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+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—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+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—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K171009LASEMD Laser SystemLutronic Corporation20178—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+7K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+7K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131839DC 7Dc International, LLC20130—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K123889Acleara, TheraclearTheravant Corporation20130—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K083008CoolskinElbio Co., Ltd.20092—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K080735CryominiZimmer Elektromedizin GmbH20081—