BEUDAMED
    Product Code: QKL FDA class 2 21 CFR 878.5040

    Lipoaspirate Washing System For Aesthetic Body Contouring

    General, Plastic Surgery

    The Lipoaspirate Washing System For Aesthetic Body Contouring is a Class 2 general and plastic surgery device intended to wash, filter, concentrate, and/or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring purposes, without further manipulation of the tissue. It requires 510(k) clearance and is regulated under 21 CFR 878.5040 within the General and Plastic Surgery medical specialty. The product code is QKL. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QKL
    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

    Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.