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510(k) Data Aggregation

    K Number
    K053475
    Device Name
    OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
    Manufacturer
    REFRACTEC, INC.
    Date Cleared
    2006-03-03

    (79 days)

    Product Code
    HMR
    Regulation Number
    886.4570
    Why did this record match?
    Applicant Name (Manufacturer) :

    REFRACTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for wind regally subsequent ophthalmic surgical manipulation.
    Device Description
    OptiPoint Corneal Template
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    K Number
    K980522
    Device Name
    REFRACTEC MCS-100
    Manufacturer
    REFRACTEC, INC.
    Date Cleared
    1998-07-22

    (162 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    REFRACTEC, INC.

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

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