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

    LITEPORT LP100 SURGICAL ILLUMINATOR

    K Number: K041621 · Decision Sep 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    LITEPORT LP100 SURGICAL ILLUMINATOR
    K Number
    K041621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Vision Industries, Inc.
    Date Received
    June 16, 2004
    Decision Date
    September 13, 2004
    Product Code
    FTF
    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
    FTF Illuminator, Non-Remote

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