510(k) Report

Devices descending from K022568

1,127 later devices reach Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K191086ExciplexClarteis20194—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K192430Epic 980Biolase, Inc.20195—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183566CLARITY II Laser SystemLutronic Corporation201911
+6K182173Joule SystemSciton, Inc20195—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K162512truSculptCutera, Inc.20165—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161503ORIONYerim Engineering Co., Ltd.20161—
+6K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+6K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+6K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150724SculpSureCynosure, Inc.201521—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150230SculpSureCynosure, Inc.201521—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K143109XP300BTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K141986Elux 810 LaserEquipmed North America, Inc.20150—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+6K141555AdvantageLutronic Corporation201414—