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510(k) Data Aggregation

    K Number
    K981665
    Device Name
    SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
    Manufacturer
    BIO-MEDICAL SCIENCES, INC.
    Date Cleared
    1998-12-07

    (210 days)

    Product Code
    MMQ
    Regulation Number
    886.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.
    Device Description
    The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents. The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.
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