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510(k) Data Aggregation

    K Number
    K984540
    Device Name
    KERAVISION VACUUM RING SYSTEM
    Manufacturer
    KERAVISION, INC.
    Date Cleared
    1999-04-28

    (128 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERAVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KeraVision® Intacs™ Vacuum System ("the Vacuum System") is intended to be used to fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea. The KeraVision Intacs™Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia.
    Device Description
    The Vacuum System primarily consists of the VCG, a vacuum pump, a tubing set with filtration, and dissectors (clockwise and counterclockwise).
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