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

    LASE SYSTEM II

    K Number: K853927 · Decision Oct 16, 1985
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    LASE SYSTEM II
    K Number
    K853927
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    James L. Geraci & Associates, Inc.
    Date Received
    September 24, 1985
    Decision Date
    October 16, 1985
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

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    K820078 DRAPE, SURGICAL
    K811698 CARL ZEISS INN MYRINGOTOMY TUBE LINE