Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151768
    Device Name
    Menicon Saline Rinse Solution
    Manufacturer
    MENICON CO.,LTD.
    Date Cleared
    2015-08-28

    (59 days)

    Product Code
    LPN, MRC
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
    Device Description
    The Menicon Saline Rinse Solution is a sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution indicated for rinsing soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. This sterile, normal saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.
    Ask a Question

    Page 1 of 1