510(k) Report

Devices descending from K031988

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+5K192224BTL-899Btl20198—
+5K191855EmFace DeviceInmode MD, Ltd.20191—
+5K181095RF-ReliefEl Global Trade, Ltd.20181—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K172302InMode PLUS SystemInmode MD, Ltd.201713—
+5K172004truSculptCutera, Inc.20173—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+5K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K250734OptiLUV DevicePollogen, Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230167BACK 4Swims America Corp20230—
+6K230037BACK 3Swims America Corp20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K221407truSculpt iDCutera, Inc.20222—
+6K213534PHantom TrilogyResurgeonz, LLC20220—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202199BTL-899STBtl20216—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K193656SkyPulseFotona D.O.O.202011—
+6K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K173285Joule SystemSciton, Inc20185—
+6K170709CURVE Laser SystemYolo Medical, Inc.20170—
+6K160470SculpSureCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K140120EPIC 10Biolase, Inc.20141—
+6K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K132976AdvatxAdvalight Aps20141—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+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—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—