510(k) Report

Devices descending from K031988

450 later devices reach Aurora DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K223680Eneka ProTermosalud20230—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K213344BTL-899ABTL Industries, Inc.20222—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K192970SlimusHironic Co., Ltd.20200—
+8K200693K2 MobileHulaser, Inc.20202—
+8K202041Opera EvoQuanta System Spa20200—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K193486Epic 980Biolase, Inc.20202—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K191086ExciplexClarteis20194—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+8K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+8K180044SIROLaser BlueDentsply Sirona201812—
+8K171992SculpSureCynosure, Inc.20178—
+8K171227StarWalkerFotona D.O.O.20177—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K163128Epic ProBiolase, Inc.201716—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+8K152714Quanta ForteQuanta System Spa201513—
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K252561BTL-754FFBTL Industries, Inc.20260—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+9K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+9K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K241656Eneka SelectifTermosalud20241—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K234057NirvanaEl.En S.P.A.20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K233024Alma HarmonyAlma Lasers, Inc.20241—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K232236EchoQuanta System Spa20230—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K230467BTL-899FBTL Industries, Inc.20231—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—