510(k) Report

Devices descending from K004005

49 later devices reach Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.200441
+1K022051Soundvaser SystemSound Surgical Technologies, LLC2002482
+2K113128Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC201212
+2K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC201151
+2K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+2K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik20053—
+2K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.200436—
+3K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation20251—
+3K190551VASERlipo SystemSolta Medical20192—
+3K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+3K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC20121—
+3K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095—
+3K072587Cytori Aft SystemCytori Therapeutics, Inc.200734—
+3K063235Cytori Lipoplasty System with Celase ReagentCytori Therapeutics, Inc.20070—
+4K254135LipoSurg ARTISTNouvag AG20260—
+4K212969LiposaverLhbiomed Co., Ltd.20241—
+4K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—
+4K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc.20120—
+4K100114Fat Concentration SystemBiomet, Inc.20108—
+4K101713Lipcollector IIHuman Med AG20103—
+4K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102—
+4K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.2009178
+4K081848Lipose Fat Transfer SystemLipose Corp.200812—
+5K252495Lssa (NP-200)Newpong Co., Ltd.20260—
+5K190386KTA Adipose Treatment KitStemics S.A.S20190—
+5K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+5K141713Smartgraft 200 SystemIngeneron, Inc.20140—
+5K141591Smartgraft 30 SystemIngeneron, Inc.20140—
+5K132815Puregraft 50 SystemCytori Therapeutics, Inc.20140—
+5K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.201271
+5K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122—
+5K120902GID 700The Gid Group, Inc.2012111
+5K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc.20121—
+5K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp.20100—
+6K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+6K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+6K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+6K172717Automatic Tissue Processing UnitBsl Co.20180—
+6K172714LipiVageGenesis Biosystems, Inc.20170—
+6K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+6K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp.20150—
+6K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151—
+6K142682The Lipogems SystemLipogems International Spa20146—
+7K161636Lipogems SystemLipogems International Spa20165—
+8K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+8K182732JTL-250-01Jointechlabs, Inc.20190—
+8K171135Lipogems SystemLipogems International Spa20172—
+9K193363Dermapose RefreshPuregraft, LLC20201—
+10K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.20210—