Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Devices at the Point of Care To Produce a Therapeutic Article
On September 13, 2021, fat transfer devices with product code MUU that process adipose tissue for return to the body for the purpose of aesthetic body contouring were transferred from CDRH to CBER for regulation. This transfer is part of an effort to consolidate regulatory oversight responsibilities in CBER for devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care to produce a therapeutic article.
As a result of this transfer, these devices were assigned new 510(k) numbers. Additionally, CBER created two new product codes under the existing suction lipoplasty system regulation (21 CFR 878.5040) to better distinguish between suction lipoplasty system technologies/functions:
QKL, Lipoaspirate processing system for aesthetic body contouring
Definition: Wash, filter, concentrate, and/or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation.
Physical State: May include tubes, filter, sieve, canister, centrifuge, non-enzymatic wash solution. The system should be used with a legally-marketed vacuum or aspirator apparatus as a source of suction. Should not use enzymatic digestion or cell selection.
Technical Method: Aspirated fat is washed, cleansed, rinsed, filtered, centrifuged, and/or fragmented without further manipulation such as cell selection or enzymatic digestion.
Target Area: Aesthetic body contouring of soft tissues.
QUB, Suction Lipoplasty System for Removal and Transfer
Definition: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring.
Physical State: May include powered suction pump system, tubes, canisters, cannulas, syringes.
Technical Method: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring.
Target Area: Aesthetic body contouring of soft tissues.
The transferred MUU devices were reassigned to these new product codes, and the new product codes will be used for new devices regulated by CBER that are intended to process adipose tissue for return to the body for the purpose of aesthetic body contouring. Suction lipoplasty systems regulated by CBER will no longer be assigned the MUU product code.
The transferred devices are listed in the table below with their corresponding new CBER 510(k) number and product code(s). The list of new CBER 510(k) numbers also include links to supporting documents (e.g., administrative letter, original clearance letter, indications for use, 510(k) summary, etc.). The 510(k) holders for the transferred devices were informed of their new CBER 510(k) numbers and new product codes via letter. Submissions, communications, and required reports for these devices should be directed to CBER.
Applicants citing any of the transferred devices below as a predicate(s) when submitting a new 510(k) premarket notification for a product intended to process adipose tissue for return to the body for the purpose of aesthetic body contouring should refer to the CBER 510(k) number listed below.
| Former CDRH 510(k) Number | Applicant | Device Name | Decision Date | New CBER 510(k) Number | New Product Code(s) |
|---|---|---|---|---|---|
| K072587 | CYTORI THERAPEUTICS INC. | CYTORI AFT SYSTEM | 12/10/2007 | BK220684 | QKL, QUB |
| K081848 | LIPOSE CORP. | LIPOSE FAT TRANSFER SYSTEM | 12/4/2008 | BK220685 | QKL |
| K083455 | MEDI-KHAN USA INC | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MODEL ZLK-100 | 5/18/2009 | BK220686 | QKL, QUB |
| K092284 | MEDICAL DEVICE RESOURCE CORP. | LIPISYSTEMS AQUAVAGE MODELS AV2000 AND AV1200 | 9/1/2009 | BK220687 | QKL |
| K092482 | SHIPPERT MEDICAL TECHNOLOGIES CORP. | TISSU TRANS FILTRON MODELS 3-TT-FILTRON 2000-500 | 12/4/2009 | BK220688 | QKL |
| K092923 | CYTORI THERAPEUTICS INC. | CYTORI PUREGRAFT 250/PURE SYSTEM | 1/6/2010 | BK220689 | QKL |
| K100114 | BIOMET INC. | FAT CONCENTRATION SYSTEM | 9/29/2010 | BK220690 | QKL |
| K101713 | HUMAN MED AG | LIPCOLLECTOR II | 6/29/2010 | BK220691 | QKL |
| K102117 | SHIPPERT MEDICAL TECHNOLOGIES CORP. | TISSU TRANS FILTRON SYRINGE FILL | 8/6/2010 | BK220692 | QKL |
| K113255 | CYTORI THERAPEUTICS INC. | PUREGRAFT 850/PURE SYSTEM | 3/7/2012 | BK220693 | QKL |
| K120328 | SOUND SURGICAL TECHNOLOGIES LLC. | ORIGINS LIPOHARVESTING SYSTEM | 9/17/2012 | BK220694 | QKL |
| K120902 | THE GID GROUP INC. | GID 700 | 8/15/2012 | BK220695 | QKL |
| K121005 | HARVEST TECHNOLOGIES CORP. | ADIPREP ADIPOSE TRANSFER SYSTEM | 9/21/2012 | BK220696 | QKL, QUB |
| K121703 | MEDI-KHAN USA INC | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE | 12/7/2012 | BK220697 | QKL, QUB |
| K130152 | ANDREW TECHNOLOGIES LLC | HYDRASOLVE LIPOPLASTY SYSTEM | 4/18/2013 | BK220698 | QKL, QUB |
| K132815 | CYTORI THERAPEUTICS INC. | PUREGRAFT 50 SYSTEM | 1/24/2014 | BK220699 | QKL |
| K141591 | INGENERON INC. | SMARTGRAFT 30 SYSTEM | 9/24/2014 | BK220700 | QKL |
| K141713 | INGENERON INC. | SMARTGRAFT 200 SYSTEM | 10/28/2014 | BK220701 | QKL |
| K142073 | THIEBAUD SAS | ST'RIM | 4/29/2015 | BK220702 | QUB |
| K142682 | Lipogems International SpA | The Lipogems System | 12/22/2014 | BK220703 | QKL |
| K150156 | Ranfac Corp | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel |
10/19/2015 | BK220704 | QKL |
| K150779 | MICROAIRE SURGICAL INSTRUMENTS LLC | LipoFilter - Hospital Pack LipoFilter - Clinic Pack |
5/22/2015 | BK220705 | QKL |
| K161372 | MIAMI FAT SUPPLY | The Red Head Collection Device The Jordy Connection System |
2/24/2017 | BK220706 | QKL |
| K161636 | Lipogems International SpA | Lipogems System | 11/4/2016 | BK220707 | QKL |
| K162932 | RANFAC CORP. | Ranfac Fat Aspiration Cannula | 1/19/2017 | BK220708 | QUB |
| K163647 | LifeCell Corporation | Revolve Envi 600 Advanced Adipose System | 8/25/2017 | BK220709 | QKL |
| K170449 | Millennium Medical Technologies Inc. | Autoclavable Suction Jar with Luer Lock extension - 250 500 1000 2000 and 3000 ml Autoclavable Suction Jar without Luer Lock extension - 1500 and 2500 ml Sterile 1500 and 2500 Lids with Conical patient connection 6-10 and overflow protection |
3/31/2017 | BK220711 | QKL |
| K171135 | Lipogems International SpA | Lipogems System | 5/18/2017 | BK220712 | QKL |
| K171242 | Alma Lasers Inc. | Alma LipoFlow System | 7/14/2017 | BK220713 | QKL |
| K172714 | Genesis Biosystems Inc. | LipiVage | 12/8/2017 | BK220714 | QKL |
| K172717 | BSL Co. | Automatic Tissue Processing Unit | 5/25/2018 | BK220715 | QKL |
| K182732 | Jointechlabs, Inc. | Jtl-250-01 | 11/18/2019 | BK220716 | QKL |
| K190278 | AuraGen Aesthetics LLC | AuraGen 123 Suction Lipoplasty System (A123) | 5/3/2019 | BK220717 | QKL |
| K190386 | Stemics S.A.S. | KTA Adipose Treatment Kit | 10/10/2019 | BK220718 | QKL, QUB |
| K191564 | Emcyte Corporation | Progenikine Concentrating Sytem 25 M System | 11/7/2019 | BK220719 | QKL |
| K193363 | Puregraft LLC | Dermapose Refresh | 4/14/2020 | BK220720 | QKL |
| K193539 | LifeCell Corporation | REVOLVE ENVI 600 Advanced Adipose System | 5/28/2020 | BK220721 | QKL |
| K202443 | BSL Co., Ltd | Smart Kit Basic, Smart Kit Pro | 3/11/2021 | BK220722 | QKL |
| K203800 | Syntr Health Technologies, Inc. | Syntrfuge System | 7/2/2021 | BK220723 | QKL |
| K210528 | Millennium Medical Technologies Inc (DBA Cellmyx) | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | 3/16/2022 | BK220726 | QKL, QUB |
Submissions for these devices should be sent to CBER's document control room in accordance with the CBER Regulatory Submissions - Electronic and Paper website.
For additional information regarding this transfer, please contact CBER Office of Communication, Outreach and Development (OCOD):
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
Suction lipoplasty devices solely intended to remove fat for discard for the purpose of body contouring remain under CDRH regulation and have been assigned a new product code, QPB. Submissions, communications, and required reports for QPB devices should continue to be directed to CDRH.
Resources For You
- 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; FR Notice
- Devices Regulated by the Center for Biologics Evaluation and Research
- Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Guidance for Industry and FDA Staff