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510(k) Data Aggregation

    K Number
    K071203
    Device Name
    SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
    Manufacturer
    OPTIKEM INTERNATIONAL, INC.
    Date Cleared
    2007-06-13

    (43 days)

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

    OPTIKEM INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear. Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.
    Device Description
    Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses. Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.
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