510(k) Report

Devices descending from K954316

382 later devices reach Aurora Surgical Diode Laser System W/Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K244060eCO2 3DLutronic Corporation20250—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191086ExciplexClarteis20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172771Epic Pro 940Biolase, Inc.20171—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K141658Light ScalpelLightscalpel, LLC20142—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K232106Air Gap FiberWontech Co., Ltd.20240—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221761SoleaConvergent Dental, Inc.202201
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202041Opera EvoQuanta System Spa20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K200234Surgical laser fibersQuanta System Spa20202—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K173827LightScalpelLightscalpel, LLC20180—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—