LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182986
    Device Name
    Boston Keratoprosthesis, Type I Lucia
    Manufacturer
    Massachusetts Eye and Ear Infirmary d/b/a Boston
    Date Cleared
    2019-01-30

    (93 days)

    Product Code
    HQM, HOM
    Regulation Number
    886.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Massachusetts Eye and Ear Infirmary d/b/a Boston

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
    Device Description
    The Boston KPro, Type I Lucia is an artificial corneal device that can be used in patients with severe corneal opacity. The device consists of two components: a front plate constructed of clear polymethyl methacrylate (PMMA) plastic, and a back plate constructed of titanium that locks the device in place around a corneal donor graft. The Boston KPro, Type I Lucia is supplied with an assembly tool/pin to assist in device assembly.
    Ask a Question

    Page 1 of 1