BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P160042 · Supplement: S018 · Decision Feb 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.0 mL, Revanesse Versa+ with Lidocaine
    PMA Number
    P160042
    Supplement Number
    S018
    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 15, 2023
    Date Received
    December 21, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change to a one needle PVC tray for holding the final gel product for Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.0 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse Lips + with Lidocaine 1.0 mL, Revanesse Lips+ with Lidocaine 1.2 mL.

    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