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

    Boston Keratoprosthesis, Type I Lucia

    K Number: K182986 · Decision Jan 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    93

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Boston Keratoprosthesis, Type I Lucia
    K Number
    K182986
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.3400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Massachusetts Eye and Ear Infirmary D/B/A Boston
    Date Received
    October 29, 2018
    Decision Date
    January 30, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQM), ordered by most recent decision date.

    BOSTON KERATOPROSTHESIS OR BOSTON KPRO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DOHLMAN DOANE KERATOPROTHESIS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all