BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P800065 · Supplement: S014 · Decision Apr 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    LENS-WET(TM)
    PMA Number
    P800065
    Supplement Number
    S014
    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
    April 12, 1996
    Date Received
    May 5, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ISOTRON IRELAND LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS

    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