510(k) Report

Devices descending from K935631

1,154 later devices reach Conbio Medalex Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212082PicoreBio-Med USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K182669Youlaser CO2Quanta System Spa20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+8K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170850Alma QAlma Lasers, Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160691Acne Light Therapy WandZuko, Inc.201650—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K132754Neogen PSR SystemEnergist, Ltd.20132—
+8K131839DC 7Dc International, LLC20130—
+8K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+8K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+8K091534Lightlas Model 532Lightmed Corp.200972—
+8K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K050218Wavelight SinonWavelight Laser Technologie AG20050—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+9K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+9K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+9K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+9K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—