BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450

    K Number: K053475 · Decision Mar 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
    K Number
    K053475
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Refractec, Inc.
    Date Received
    December 14, 2005
    Decision Date
    March 3, 2006
    Product Code
    HMR
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HMR Marker, Ocular

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    Other Clearances by Refractec, Inc.

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