BEUDAMED
    Product Code: QWY FDA class 3

    Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

    Unknown

    The mechanical and enzymatic autologous skin processor for cell suspension for stable vitiligo with applicator (product code QWY) is a Class 3 device reviewed by the Hematology panel, intended for use at the patient's point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo. As a Class 3 device, it requires PMA. No regulation number has been assigned. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QWY
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    2

    Device Characteristics

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

    Definition

    Intended for use at the patient’s point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo.

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.