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 In this section:

                Development & Approval Process (CBER)

Development & Approval Process (CBER)

                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
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          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
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          Development & Approval Process (CBER)
          Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Devices at the Point of Care To Produce a Therapeutic ArticleDevelopment & Approval Process (CBER) 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
  
  	
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    PrintOn 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, QUBK081848
			LIPOSE CORP.
			LIPOSE FAT TRANSFER SYSTEM
			12/4/2008
			BK220685
			QKLK083455
			MEDI-KHAN USA INC
			LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MODEL ZLK-100
			5/18/2009
			BK220686
			QKL, QUBK092284
			MEDICAL DEVICE RESOURCE CORP.
			LIPISYSTEMS AQUAVAGE MODELS AV2000 AND AV1200
			9/1/2009
			BK220687
			QKLK092482
			SHIPPERT MEDICAL TECHNOLOGIES CORP.
			TISSU TRANS FILTRON MODELS 3-TT-FILTRON 2000-500
			12/4/2009
			BK220688
			QKLK092923
			CYTORI THERAPEUTICS INC.
			CYTORI PUREGRAFT 250/PURE SYSTEM
			1/6/2010
			BK220689
			QKLK100114
			BIOMET INC.
			FAT CONCENTRATION SYSTEM
			9/29/2010
			BK220690
			QKLK101713
			HUMAN MED AG
			LIPCOLLECTOR II
			6/29/2010
			BK220691
			QKLK102117
			SHIPPERT MEDICAL TECHNOLOGIES CORP.
			TISSU TRANS FILTRON SYRINGE FILL
			8/6/2010
			BK220692
			QKLK113255
			CYTORI THERAPEUTICS INC.
			PUREGRAFT 850/PURE SYSTEM
			3/7/2012
			BK220693
			QKLK120328
			SOUND SURGICAL TECHNOLOGIES LLC.
			ORIGINS LIPOHARVESTING SYSTEM
			9/17/2012
			BK220694
			QKLK120902
			THE GID GROUP INC.
			GID 700
			8/15/2012
			BK220695
			QKLK121005
			HARVEST TECHNOLOGIES CORP.
			ADIPREP ADIPOSE TRANSFER SYSTEM
			9/21/2012
			BK220696
			QKL, QUBK121703
			MEDI-KHAN USA INC
			LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
			12/7/2012
			BK220697
			QKL, QUBK130152
			ANDREW TECHNOLOGIES LLC
			HYDRASOLVE LIPOPLASTY SYSTEM
			4/18/2013
			BK220698
			QKL, QUBK132815
			CYTORI THERAPEUTICS INC.
			PUREGRAFT 50 SYSTEM
			1/24/2014
			BK220699
			QKLK141591
			INGENERON INC.
			SMARTGRAFT 30 SYSTEM
			9/24/2014
			BK220700
			QKLK141713
			INGENERON INC.
			SMARTGRAFT 200 SYSTEM
			10/28/2014
			BK220701
			QKLK142073
			THIEBAUD SAS
			ST'RIM
			4/29/2015
			BK220702
			QUBK142682
			Lipogems International SpA
			The Lipogems System
			12/22/2014
			BK220703
			QKLK150156
			Ranfac Corp
			Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack
			Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
			10/19/2015
			BK220704
			QKLK150779
			MICROAIRE SURGICAL INSTRUMENTS LLC
			LipoFilter - Hospital Pack
			LipoFilter - Clinic Pack
			5/22/2015
			BK220705
			QKLK161372
			MIAMI FAT SUPPLY
			The Red Head Collection Device
			The Jordy Connection System
			2/24/2017
			BK220706
			QKLK161636
			Lipogems International SpA
			Lipogems System
			11/4/2016
			BK220707
			QKLK162932
			RANFAC CORP.
			Ranfac Fat Aspiration Cannula
			1/19/2017
			BK220708
			QUBK163647
			LifeCell Corporation
			Revolve Envi 600 Advanced Adipose System
			8/25/2017
			BK220709
			QKLK170449
			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
			QKLK171135
			Lipogems International SpA
			Lipogems System
			5/18/2017
			BK220712
			QKLK171242
			Alma Lasers Inc.
			Alma LipoFlow System
			7/14/2017
			BK220713
			QKLK172714
			Genesis Biosystems Inc.
			LipiVage
			12/8/2017
			BK220714
			QKLK172717
			BSL Co.
			Automatic Tissue Processing Unit
			5/25/2018
			BK220715
			QKLK182732
			Jointechlabs, Inc.
			Jtl-250-01
			11/18/2019
			BK220716
			QKLK190278
			AuraGen Aesthetics LLC
			AuraGen 123 Suction Lipoplasty System (A123)
			5/3/2019
			BK220717
			QKLK190386
			Stemics S.A.S.
			KTA Adipose Treatment Kit
			10/10/2019
			BK220718
			QKL, QUBK191564
			Emcyte Corporation
			Progenikine Concentrating Sytem 25 M System
			11/7/2019
			BK220719
			QKLK193363
			Puregraft LLC
			Dermapose Refresh
			4/14/2020
			BK220720
			QKLK193539
			LifeCell Corporation
			REVOLVE ENVI 600 Advanced Adipose System
			5/28/2020
			BK220721
			QKLK202443
			BSL Co., Ltd
			Smart Kit Basic, Smart Kit Pro
			3/11/2021
			BK220722
			QKLK203800
			Syntr Health Technologies, Inc.
			Syntrfuge System
			7/2/2021
			BK220723
			QKLK210528
			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

                                                                                  Content current as of:
      05/02/2023Development & Approval Process (CBER)

          
                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products
 
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