510(k) Report

Devices descending from K962446

1,497 later devices reach Sharplan Ruby Laser System 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—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K191086ExciplexClarteis20194—
+7K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+7K192430Epic 980Biolase, Inc.20195—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K192331LaseMD LEO Laser SystemLutronic Global20190—
+7K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd.201966—
+7K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+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—
+7K183566CLARITY II Laser SystemLutronic Corporation201911
+7K182173Joule SystemSciton, Inc20195—
+7K183217IPL Hair Removal DeviceTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.20193—
+7K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+7K182669Youlaser CO2Quanta System Spa20181—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K180338CellulizeWard Photonics, LLC20182—
+7K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd.201836—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K180383Light based hair removal deviceShenzhen Gsd Tech Co., Ltd.20181—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K180016Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd.201825—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172111Vevazz LEDVevazz, LLC20170—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+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—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K163415SlimShape SystemSyneron Medical, Ltd.201714—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+7K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162512truSculptCutera, Inc.20165—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+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—
+7K160821Tria SapphireTria Beauty, Inc.20160—
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+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—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K143554Venus Legacy CXVenus Concept, Ltd.201517—
+7K150724SculpSureCynosure, Inc.201521—
+7K143559XP1000 RFBTL Industries, Inc.20157—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150230SculpSureCynosure, Inc.201521—