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510(k) Data Aggregation

    K Number
    K001234
    Device Name
    BIOINSULATED SILICONE PUNCTUM PLUG
    Date Cleared
    2000-07-11

    (85 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VISION SCIENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K980844
    Device Name
    SURGIDEV SILICONE PUNCTUM PLUG
    Date Cleared
    1998-05-11

    (68 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VISION SCIENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgidev Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex learing, itching or foreign body sensations which can be relieved by blockage of the punctum. The Surgidev Sillcone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as comeal ulcers, conjunctivitis, pterygium, blepharitis, keratils, red lid margins, recurrent chalazions, recurrent comeal eroston, filamentry keratitis and other external eye diseases. When indicated the Surgidev Silicone Puncture Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing ocular dryness secondary to contact lens use may also be alded by Slicone Puncturn Plugs.
    Device Description
    A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
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