BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P240022 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM
    PMA Number
    P240022
    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
    February 13, 2025
    Date Received
    June 21, 2024
    Expedited Review
    N
    Docket Number
    25M-0437

    Advisory Committee Statement

    Dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds (such as NLFs) 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