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

    S.L.T. CONTACT LASER

    K Number: K855119 · Decision Feb 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    51
    Review Days
    63

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    Basic Information

    Device Name
    S.L.T. CONTACT LASER
    K Number
    K855119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgical Laser Technologies, Inc.
    Date Received
    December 23, 1985
    Decision Date
    February 24, 1986
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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    Other Clearances by Surgical Laser Technologies, Inc.

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    K011409 SLT LASERPRO CTH HOLMIUM LASER SYSTEM
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    K984018 HEMOSLEEVE, MODEL 4.0MM, 5.5MM
    K983050 PNEUMATIC CUTTER SYSTEM
    K981041 SLT BIPOLAR SHEATH
    K972548 SLT CL MD CONTACT LASER SYSTEM
    K980156 SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
    K960821 SLT FUMICH PROBE GUIDE
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