BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P830034 · Supplement: S031 · Decision Mar 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    OPTI-FREE REWETTING DROPS
    PMA Number
    P830034
    Supplement Number
    S031
    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
    March 26, 1997
    Date Received
    December 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REDUCING THE FILL VOLUME OF OPTI-FREE(R) REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE.

    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