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510(k) Data Aggregation

    K Number
    K011561
    Device Name
    SEREINE EXTRA STRENGTH DAILY CLEANER
    Manufacturer
    WILSA, INC.
    Date Cleared
    2001-11-20

    (183 days)

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

    WILSA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sereine Extra Strength Daily Cleaner is indicated for use as a daily cleaner for removal of film, deposits and other debris which accumulate on soft (hydrophilic) and hard (PMMA) contact lenses during wear. Sereine Extra Strength Daily Cleaner may be used with either thermal (heat) or chemical (cold) disinfection systems. Follow the recommendation of your eye care practitioner when disinfecting your lenses.
    Device Description
    Sereine Extra Strength Daily Cleaner is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains an amphoteric surfactant to aid in the removal of proteins, lipids and other debris which accumulate on contact lenses during wear. The cleaner is not meant for use in the eye and must be rinsed from the lenses. Sereine Extra Strength Daily Cleaner is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyolefin) and 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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