BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P250021 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    saypha® ChiQ™
    PMA Number
    P250021
    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
    June 12, 2026
    Date Received
    June 26, 2025
    Expedited Review
    N

    Advisory Committee Statement

    saypha® ChIQ™ is indicated for use in cheek augmentation and restoring midface volume deficits in patients over the age of 21. The device is indicated to be administered by subcutaneous and/or supraperiosteal injection.

    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