BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BOSTON KERATOPROSTHESIS OR BOSTON KPRO

    K Number: K121203 · Decision May 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    385

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    Basic Information

    Device Name
    BOSTON KERATOPROSTHESIS OR BOSTON KPRO
    K Number
    K121203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Massachusetts Eye & Ear Infirmary
    Date Received
    April 20, 2012
    Decision Date
    May 10, 2013
    Product Code
    HQM
    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
    HQM Keratoprosthesis, Permanent Implant

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