BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P170002 · Supplement: S048 · Decision Sep 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RHA® Dynamic Volume, RHA®4
    PMA Number
    P170002
    Supplement Number
    S048
    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
    September 18, 2025
    Date Received
    December 2, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for RHA®4 and RHA® Dynamic Volume for expanding the indications to include injection into the subcutaneous to supraperiosteal layers for cheek augmentation and/or correction of age-related midface contour deficiencies in patients aged 22 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