System, Suction, Lipoplasty
FDA product code MUU · Class II (moderate risk) · 21 CFR 878.5040 · General, Plastic Surgery
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).
40510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Cytori Therapeutics, Inc. 4
- Lipogems International Spa 3
- Bsl Co., Ltd. 2
- Medi-Khan USA, Inc. 2
- Lifecell Corp. 2
- Shippert Medical Technologies 2
- Ranfac, Corp. 2
- Ingeneron, Inc. 2
- Andrew Technologies, LLC 1
- Millennium Medical Technologies Inc (Dba Cellmyx) 1
- Millennium Medical Technologies, Inc. 1
- Miami Fat Supply 1
- MicroAire Surgical Instruments, LLC 1
- Thiebaud Sas 1
- Harvest Technologies, Corp. 1
- Sound Surgical Technologies, LLC 1
- The Gid Group, Inc. 1
- Biomet, Inc. 1
- Human Med AG 1
- Medical Device Resource Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…MUU · Traditional | Millennium Medical Technologies Inc (Dba Cellmyx) | 03/16/2022SE |
| K203800 | SyntrFuge SystemMUU · Traditional | Syntr Health Technologies, Inc. | 07/02/2021SE |
| K202443 | Smart Kit Basic, Smart Kit ProMUU · Traditional | Bsl Co., Ltd. | 03/11/2021SE |
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | Lifecell Corporation | 05/28/2020SE |
| K193363 | Dermapose RefreshMUU · Traditional | Puregraft, LLC | 04/14/2020SE |
| K182732 | JTL-250-01MUU · Traditional | Jointechlabs, Inc. | 11/18/2019SE |
| K191564 | Progenikine Concentrating System 25 mL SystemMUU · Traditional | Emcyte Corporation | 11/07/2019SE |
| K190386 | KTA Adipose Treatment KitMUU · Traditional | Stemics S.A.S | 10/10/2019SE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional | Auragen Aesthetics, LLC | 05/03/2019SE |
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | Bsl Co. | 05/25/2018SE |
| K172714 | LipiVageMUU · Traditional | Genesis Biosystems, Inc. | 12/08/2017SE |
| K163647 | Revolve Envi 600 Advanced Adipose SystemMUU · Traditional | Lifecell Corporation | 08/25/2017SE |
| K171242 | Alma LipoFlow SystemMUU · Traditional | Alma Lasers, Inc. | 07/14/2017SE |
| K171135 | Lipogems SystemMUU · Traditional | Lipogems International Spa | 05/18/2017SE |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml…MUU · Traditional | Millennium Medical Technologies, Inc. | 03/31/2017SE |
| K161372 | The Red Head Collection Device, The Jordy Connection SystemMUU · Traditional | Miami Fat Supply | 02/24/2017SE |
| K162932 | Ranfac Fat Aspiration CannulaMUU · Traditional | Ranfac, Corp. | 01/19/2017SE |
| K161636 | Lipogems SystemMUU · Traditional | Lipogems International Spa | 11/04/2016SE |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…MUU · Traditional | Ranfac, Corp. | 10/19/2015SE |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackMUU · Traditional | Microaire Surgical Instruments, LLC | 05/22/2015SE |
| K142073 | St'RimMUU · Traditional | Thiebaud Sas | 04/29/2015SE |
| K142682 | The Lipogems SystemMUU · Traditional | Lipogems International Spa | 12/22/2014SE |
| K141713 | Smartgraft 200 SystemMUU · Traditional | Ingeneron, Inc. | 10/28/2014SE |
| K141591 | Smartgraft 30 SystemMUU · Traditional | Ingeneron, Inc. | 09/24/2014SE |
| K132815 | Puregraft 50 SystemMUU · Traditional | Cytori Therapeutics, Inc. | 01/24/2014SE |
| K130152 | Hydrasolve Lipoplasty SystemMUU · Traditional | Andrew Technologies, LLC | 04/18/2013SE |
| K121703 | Lipokit with Disposable 50CC Aft SyringeMUU · Special | Medi-Khan USA, Inc. | 12/07/2012SE |
| K121005 | Adiprep Adipose Transfer SystemMUU · Traditional | Harvest Technologies, Corp. | 09/21/2012SE |
| K120328 | Origins Lipoharvesting SystemMUU · Traditional | Sound Surgical Technologies, LLC | 09/17/2012SE |
| K120902 | Gid 700MUU · Traditional | The Gid Group, Inc. | 08/15/2012SE |
| K113255 | Puregraft 850/PURE SystemMUU · Traditional | Cytori Therapeutics, Inc. | 03/07/2012SE |
| K100114 | Fat Concentration SystemMUU · Traditional | Biomet, Inc. | 09/29/2010SE |
| K102117 | Tissu Trans Filtron Syringe FillMUU · Special | Shippert Medical Technologies Corp. | 08/06/2010SE |
| K101713 | Lipcollector IIMUU · Traditional | Human Med AG | 06/29/2010SE |
| K092923 | Cytori Puregraft 250/PURE SystemMUU · Traditional | Cytori Therapeutics, Inc. | 01/06/2010SE |
| K092482 | Tissu Trans Filtron, Models 3-TT-FILTRON 2000-500MUU · Traditional | Shippert Medical Technologies Corp. | 12/04/2009SE |
| K092284 | Lipisystems Aquavage, Models AV2000 and AV1200MUU · Special | Medical Device Resource Corp. | 09/01/2009SE |
| K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100MUU · Traditional | Medi-Khan USA, Inc. | 05/18/2009SE |
| K081848 | Lipose Fat Transfer SystemMUU · Traditional | Lipose Corp. | 12/04/2008SE |
| K072587 | Cytori Aft SystemMUU · Traditional | Cytori Therapeutics, Inc. | 12/10/2007SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1336-2019 Class II | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1335-2019 Class II | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1334-2019 Class II | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1333-2019 Class II | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1332-2019 Class II | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1331-2019 Class II | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-1330-2019 Class II | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use.…The pouch integrity of the sterile product can't be assured without a visual examination due to possibly… | Shippert Medical Technologies | 02/02/2018Completed |
| Z-0170-2018 Class II | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and…Potential breach of sterility of the packaging. | Shippert Medical Technologies | 10/20/2017Terminated |
| Z-0823-2018 Class II | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring…Presence of bacterial endotoxins levels above the acceptable limit | LifeCell Corporation, A Wholly Owned… | 08/08/2017Terminated |
| Z-0674-2017 Class II | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the… | Terumo BCT, Inc. | 11/03/2016Terminated |
| Z-1957-2016 Class II | The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended…During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved… | Miami Fat Supply, Inc | 04/21/2016Terminated |
| Z-0690-2016 Class II | Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G…The cannulae may bend during procedure. | Globalmed Logistix | 12/15/2015Terminated |
| Z-2822-2015 Class II | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.There is potential risk of electrical shock if lead wires inside the device become detached and the ground… | MicroAire Surgical Instruments, LLC | 06/12/2015Terminated |
| Z-2821-2015 Class II | ASP-1020 LipoTower with Aspiration Pump. Medical use.There is potential risk of electrical shock if lead wires inside the device become detached and the ground… | MicroAire Surgical Instruments, LLC | 06/12/2015Terminated |
| Z-1230-2007 | 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number…Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic… | Mentor Texas, Inc | 07/27/2007Terminated |