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

    OPTICAL INTEGRITY LASERGUARD FIBERS

    K Number: K100194 · Decision May 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    OPTICAL INTEGRITY LASERGUARD FIBERS
    K Number
    K100194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Integrity, Inc.
    Date Received
    January 22, 2010
    Decision Date
    May 20, 2010
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Optical Integrity, Inc.

    K Number Device Name
    K022338 OPTICAL INTEGRITY GENERAL SHAPED FIBER