BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P250020 · Decision May 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Belotero Volume (+) Lidocaine
    PMA Number
    P250020
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 2026
    Date Received
    June 26, 2025
    Expedited Review
    N

    Advisory Committee Statement

    Approval for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years or older

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMH Implant, Dermal, For Aesthetic Use