BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P090016 · Supplement: S067 · Decision May 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine
    PMA Number
    P090016
    Supplement Number
    S067
    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 3, 2026
    Date Received
    August 27, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the use of sodium hyaluronate raw material manufactured at a new supplier production line

    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