510(k) Report

Devices descending from K960032

1,152 later devices reach Coherent Versapulse Aesthetic Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K191086ExciplexClarteis20194—
+6K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183247dpl FacewareLed Technologies, Inc.201910—
+6K182173Joule SystemSciton, Inc20195—
+6K183118dpl SpotLiteLed Technologies, Inc.201922—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K180875Poly RejuvMedtek Skincare, LLC20180—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+6K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+6K1718212 Face / Face EvolutionHeat IN A Click201858—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+6K141555AdvantageLutronic Corporation201414—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122493GenesisplusCutera, Inc.201318—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123889Acleara, TheraclearTheravant Corporation20130—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083008CoolskinElbio Co., Ltd.20092—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—