510(k) Report

Devices descending from K021149

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K081408Ellipse MultiflexEllipse A/S20087—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K250200InbellaBody SystemInbella Medical, Inc.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K240311JETT Medical IICompex, Spol, S.R.O.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243929Oligio XWontech Co., Ltd.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K230167BACK 4Swims America Corp20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K230037BACK 3Swims America Corp20230—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K223680Eneka ProTermosalud20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K221407truSculpt iDCutera, Inc.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202199BTL-899STBtl20216—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192430Epic 980Biolase, Inc.20195—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—