BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P830034 · Supplement: S033 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION
    PMA Number
    P830034
    Supplement Number
    S033
    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
    March 19, 1997
    Date Received
    March 4, 1997
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS: "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."

    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