BEUDAMED
    Product Code: MUU FDA class 2 21 CFR 878.5040

    System, Suction, Lipoplasty

    General, Plastic Surgery

    A Lipoplasty Suction System is a device used in liposuction (lipoplasty) procedures to aspirate and remove subcutaneous adipose tissue from targeted body areas, using controlled negative pressure delivered through cannulas. It is FDA Class 2, requiring 510(k) clearance, with product code MUU under 21 CFR 878.5040 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    40
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    30
    Years Active
    14

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    Basic Information

    Product Code
    MUU
    Device Class
    FDA class 2
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    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).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 40 510(k) clearances via K numbers.

    K Number Device Name
    K210528 IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
    K203800 SyntrFuge System
    K202443 Smart Kit Basic, Smart Kit Pro
    K193539 REVOLVE ENVI 600 Advanced Adipose System
    K193363 Dermapose Refresh
    K182732 JTL-250-01
    K191564 Progenikine Concentrating System 25 mL System
    K190386 KTA Adipose Treatment Kit
    K190278 AuraGen 123 Suction Lipoplasty System (A123)
    K172717 Automatic Tissue Processing Unit
    K172714 LipiVage
    K163647 Revolve Envi 600 Advanced Adipose System
    K171242 Alma LipoFlow System
    K171135 Lipogems System
    K170449 Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
    K161372 The Red Head Collection Device, The Jordy Connection System
    K162932 Ranfac Fat Aspiration Cannula
    K161636 Lipogems System
    K150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
    K150779 LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
    K142073 ST'RIM
    K142682 The Lipogems System
    K141713 SMARTGRAFT 200 SYSTEM
    K141591 SMARTGRAFT 30 SYSTEM
    K132815 PUREGRAFT 50 SYSTEM
    K130152 HYDRASOLVE LIPOPLASTY SYSTEM
    K121703 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
    K121005 ADIPREP ADIPOSE TRANSFER SYSTEM
    K120328 ORIGINS LIPOHARVESTING SYSTEM
    K120902 GID 700
    K113255 PUREGRAFT 850/PURE SYSTEM
    K100114 FAT CONCENTRATION SYSTEM
    K102117 TISSU TRANS FILTRON SYRINGE FILL
    K101713 LIPCOLLECTOR II
    K092923 CYTORI PUREGRAFT 250/PURE SYSTEM
    K092482 TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
    K092284 LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
    K083455 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
    K081848 LIPOSE FAT TRANSFER SYSTEM
    K072587 CYTORI AFT SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.