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

    MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER

    K Number: K955861 · Decision Jan 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    6
    Review Days
    30

    Basic Information

    Device Name
    MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER
    K Number
    K955861
    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
    MICROQUARTZ MEDICAL, INC.
    Date Received
    December 27, 1995
    Decision Date
    January 26, 1996
    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 MICROQUARTZ MEDICAL, INC.

    K Number Device Name
    K954904 MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER
    K953065 ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)
    K953174 MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY
    K952974 QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER)
    K950710 MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER