BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P850088 · Supplement: S036 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    ULTRA CARE (TM) NEUTRALIZING TABLET
    PMA Number
    P850088
    Supplement Number
    S036
    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
    July 3, 1997
    Date Received
    August 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE FORMULATION USING CATALASE RAW MATERIAL DERIVED FROM A NON-ANIMAL SOURCE AND AN ASSOCIATED CHANGE IN THE MINIMUM NEUTRALIZATION SOAK TIME FROM 2 TO 4 HOURS. THE ALTERNATE FORMULATION INCLUDES NO CHANGES IN THE INDICATIONS FOR USE.

    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