BEUDAMED
    Product Code: QUB FDA class 2 21 CFR 878.5040

    Suction Lipoplasty System For Removal And Transfer

    General, Plastic Surgery

    The Suction Lipoplasty System for Removal and Transfer is a surgical device used to remove autologous adipose (fat) tissue via suction and transfer or reimplant it elsewhere in the body without further manipulation, for the purpose of aesthetic body contouring. The procedure combines liposuction with fat grafting in a single system. Classified as FDA Class 2 under regulation 878.5040, it requires 510(k) clearance in the General and Plastic Surgery specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QUB
    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

    Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.