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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?
    Product Code :

    MMQ

    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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    K Number
    K964702
    Device Name
    EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
    Manufacturer
    EUCLID SYSTEMS CORP.
    Date Cleared
    1997-05-20

    (176 days)

    Product Code
    MMQ
    Regulation Number
    886.1350
    Why did this record match?
    Product Code :

    MMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the comea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.
    Device Description
    Not Found
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    K Number
    K964891
    Device Name
    ORBSHOT KERATOMETER
    Manufacturer
    ORBTEK, INC.
    Date Cleared
    1997-03-26

    (110 days)

    Product Code
    MMQ
    Regulation Number
    886.1350
    Why did this record match?
    Product Code :

    MMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963762
    Device Name
    CORNEAL TOPOGRAPHER 200
    Manufacturer
    ECLIPSE VENTURES
    Date Cleared
    1996-12-23

    (95 days)

    Product Code
    MMQ
    Regulation Number
    886.1350
    Why did this record match?
    Product Code :

    MMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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