BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P170002 · Supplement: S050 · Decision May 12, 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
    RHA Redensity® Eye Lido; RHA Redensity® Eye
    PMA Number
    P170002
    Supplement Number
    S050
    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 12, 2026
    Date Received
    August 29, 2025
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for RHA Redensity® Eye Lido and RHA Redensity® Eye for expanding the indications to include injection into the sub-dermis and supraperiosteum for the correction of moderate to severe tissue volume deficiencies in the infraorbital region in adults aged 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