BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P900047 · Supplement: S005 · Decision Jun 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    CLARIS(TM) REWETTING DROPS
    PMA Number
    P900047
    Supplement Number
    S005
    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
    June 20, 1996
    Date Received
    March 1, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO 1)DUPLICATE WET-N-SOAK REWETTING DROPS UNDER THE TRADE NAME CLARIS REWETTING DROPS TO BE USED WITH CLARIS CLEANING AND SOAKING SOLUTION (ALLERGAN'S TRADE NAME FOR DESTAT 4 CLEANING, DISINFECTING, STORAGE SOLUTION (P870023)) AND 2)ADD THE FOLLOWING TO THE DIRECTIONS SECTION FOR CLARIS REWETTING DROPS: BEFORE WEARING LENSES: PLACE 1 OR 2 DROPS OF CLARIS REWETTING DROPS ON EACH SIDE OF EACH LENS BEFORE APPLICATION

    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