BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P830034 · Supplement: S026 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION
    PMA Number
    P830034
    Supplement Number
    S026
    Device Class
    FDA Class 2
    Product Code
    LPN
    Generic Name
    Accessories, soft lens products
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 31, 1995
    Date Received
    February 10, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF A MULTI-PURPOSE SOLUTION FOR CLEANING, RINSING, DISINFECTING, AND STORING SOFT (HYDROPHILIC) CONTACT LENSES. THIS DEVICE IS A MODIFICATION OF THE APPROVED OPTI-FREE RINSING, DISINFECTING, AND STORAGE SOLUTION DUE TO THE ADDITION OF LOW CONCENTRATIONS OF SURFACTANTS. THE SOLUTION WILL BE MARKETED IN 1.5FL.OZ, 4FL.OZ., 8FL.OZ., 12FL.OZ., & 16FL.OZ. SIZE BOTTLES

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products