510(k) Report

Devices descending from K962525

54 later devices reach Ultra-Safe Ultrasonic Aspirator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980895Allegro Ultrasonic Soft Tissue AspiratorCalifornia Institute of Tissue Eng. & Instrumenti19980—
+1K972958Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond CannulasLysonix, Inc.19970—
+1K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.199752—
+2K022051Soundvaser SystemSound Surgical Technologies, LLC2002482
+2K004005Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis…Mentor Corp.200149—
+2K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp.199849—
+3K113128Microaire Surgical Instruments LLCMicroaire Surgical Instruments, LLC201212
+3K110306Sound Surgical Vaser 2.1 Lipo SystemSound Surgical Technologies, LLC201151
+3K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.200436—
+3K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.200441
+4K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation20251—
+4K190551VASERlipo SystemSolta Medical20192—
+4K171242Alma LipoFlow SystemAlma Lasers, Inc.20170—
+4K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102—
+4K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095—
+4K072587Cytori Aft SystemCytori Therapeutics, Inc.200734—
+4K063235Cytori Lipoplasty System with Celase ReagentCytori Therapeutics, Inc.20070—
+4K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik20053—
+5K254135LipoSurg ARTISTNouvag AG20260—
+5K212969LiposaverLhbiomed Co., Ltd.20241—
+5K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC20121—
+5K121703Lipokit with Disposable 50CC Aft SyringeMedi-Khan USA, Inc.20120—
+5K100114Fat Concentration SystemBiomet, Inc.20108—
+5K101713Lipcollector IIHuman Med AG20103—
+5K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102—
+5K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.2009178
+5K081848Lipose Fat Transfer SystemLipose Corp.200812—
+6K252495Lssa (NP-200)Newpong Co., Ltd.20260—
+6K190386KTA Adipose Treatment KitStemics S.A.S20190—
+6K170449Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…Millennium Medical Technologies, Inc.20170—
+6K141713Smartgraft 200 SystemIngeneron, Inc.20140—
+6K141591Smartgraft 30 SystemIngeneron, Inc.20140—
+6K132815Puregraft 50 SystemCytori Therapeutics, Inc.20140—
+6K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC20130—
+6K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.201271
+6K120328Origins Lipoharvesting SystemSound Surgical Technologies, LLC20122—
+6K120902GID 700The Gid Group, Inc.2012111
+6K113255Puregraft 850/Pure SystemCytori Therapeutics, Inc.20121—
+6K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp.20100—
+7K203800SyntrFuge SystemSyntr Health Technologies, Inc.20210—
+7K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation20200—
+7K190278AuraGen 123 Suction Lipoplasty System (A123)Auragen Aesthetics, LLC20190—
+7K172717Automatic Tissue Processing UnitBsl Co.20180—
+7K172714LipiVageGenesis Biosystems, Inc.20170—
+7K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation20170—
+7K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…Ranfac, Corp.20150—
+7K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC20151—
+7K142682The Lipogems SystemLipogems International Spa20146—
+8K161636Lipogems SystemLipogems International Spa20165—
+9K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…Millennium Medical Technologies Inc (Dba Cellmyx)20220—
+9K182732JTL-250-01Jointechlabs, Inc.20190—
+9K171135Lipogems SystemLipogems International Spa20172—
+10K193363Dermapose RefreshPuregraft, LLC20201—
+11K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.20210—