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

    CORNEAL LIGHT SHIELD

    K Number: K850270 · Decision May 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    13
    Applicant Total
    18
    Review Days
    128

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    Basic Information

    Device Name
    CORNEAL LIGHT SHIELD
    K Number
    K850270
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4700
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mentor O & O, Inc.
    Date Received
    January 23, 1985
    Decision Date
    May 31, 1985
    Product Code
    HRM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

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