BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P140029 · Supplement: S054 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Restylane® Contour
    PMA Number
    P140029
    Supplement Number
    S054
    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
    March 20, 2026
    Date Received
    July 24, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    26M-2916

    Advisory Committee Statement

    Approval for expanding the indications of Restylane Contour for correction of temple hollowing in patients over the age of 21.

    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