510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121435Silkn BlueHome Skinovations, Ltd.2013125—
+6K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+6K122237Biophotas LifelightBiophotas, Inc.201371—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K121091Catalys Precision Laser SystemOptimedica Corporation2012122
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K093168Mediflash and EsteflashDermeo20100—
+6K090744CLAROClrs Technology Corporation20101—
+6K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+6K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+6K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+6K090724OR-LightYperion Technology20090—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K083008CoolskinElbio Co., Ltd.20092—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083730IsolazAesthera Corporation20093—
+6K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K080735CryominiZimmer Elektromedizin GmbH20081—
+6K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+6K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+6K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+6K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+6K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+6K063828Diomed Delta 25Diomed, Ltd.20075—
+6K063249BeamaxMedic Sharplight, Ltd.200758—
+6K062369Iridex Oculight TXIridex Corp200673—
+6K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+6K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+6K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+6K053324Chromolite SystemChromogenex Plc200631—
+6K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+6K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+6K041969Aurora DSSyneron Medical, Ltd.2004302—
+6K040384Mydon CWavelight Laser Technologie AG200451—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—