BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P830071 · Supplement: S008 · Decision May 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
    PMA Number
    P830071
    Supplement Number
    S008
    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
    May 15, 1997
    Date Received
    December 18, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERANTE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.

    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