BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Solution, Ultrasonic Cleaners For Lenses

    PMA: P960024 · Supplement: S001 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Accessories, Solution, Ultrasonic Cleaners For Lenses
    Trade Name
    UNIZYME(TM) ENZYMATIC CLEANER
    PMA Number
    P960024
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    LYL
    Generic Name
    Accessories, solution, ultrasonic cleaners for lenses
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 3, 1997
    Date Received
    April 15, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of Ciba Vision's SOLOCare(TM) Brand Multi-Purpose Solution to the labeling of the Unizyme(TM) Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme(TM) enzyme.

    Classifications

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

    Product Code Device Name
    LYL Accessories, Solution, Ultrasonic Cleaners For Lenses