510(k) Report

Devices descending from K021149

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K202780SectumNeauvia North America20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K192621Medical RFTriworks Group Srl20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K183450EmBody SystemInmode MD, Ltd.20198—
+5K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+5K172413MT ONEM&T S.R.L.20175—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K162512truSculptCutera, Inc.20165—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K152611V20 systemViora, Ltd.20164—
+5K152714Quanta ForteQuanta System Spa201513—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K142093V20 SystemViora, Ltd.201432—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K132976AdvatxAdvalight Aps20141—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K111501I-Lipo SystemChromogenex Technologies Limited201215—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111026ApolloPollogen, Ltd.201114—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+5K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253504Volnewmer™Classys, Inc.20260—
+6K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—