BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P220009 · Decision Feb 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
    PMA Number
    P220009
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 22, 2023
    Date Received
    July 7, 2022
    Expedited Review
    N
    Docket Number
    23M-0607

    Advisory Committee Statement

    Approval for the StableVisc Ophthalmic Viscosurgical Device (OVD). StableVisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:1) Extraction of a cataract; and2) Implantation of an intraocular lens (IOL).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic