510(k) Report

Devices descending from K021149

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031489PitangaSyneron Medical, Ltd.20030—
+1K031988Aurora DSSyneron Medical, Ltd.2003450—
+1K024064Polaris DSSyneron Medical, Ltd.2003681—
+2K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+2K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+2K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+2K030186Polris LVSyneron Medical, Ltd.2003680—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K090221Reaction SystemViora, Ltd.200954—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+3K071872VelashapeSyneron Medical, Ltd.2007127—
+3K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+3K061603SmoothshapesBiocellulase, Inc.200648—
+3K053611SmoothshapesBicellulase, Inc.200695—
+3K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K143554Venus Legacy CXVenus Concept, Ltd.201517—
+4K150035V10 systemViora, Ltd.201531—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141904Viora V-TouchViora, Ltd.20140—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K120510TranscendSyneron Medical, Ltd.201318—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K122579VelashapeSyneron Medical, Ltd.20124—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083629SmoothshapesEleme Medical, Inc.200927—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250852CoolfaseAsterasys Co., Ltd.20250—
+5K251327XERFLutronic Corporation202501
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+5K242241SunnyShenB Co., Ltd.20250—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240248Volnewmer™Classys, Inc.20241—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K23299210THERMATentech, Inc.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K22079410PLTentech Co., Ltd.20220—
+5K221989The OligioWontech Co., Ltd.20222—
+5K212561MTX-C1Ilooda Co,., Ltd.20220—