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

    S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA

    K Number: K855095 · Decision Feb 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    51
    Review Days
    57

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    Basic Information

    Device Name
    S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
    K Number
    K855095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Surgical Laser Technologies, Inc.
    Date Received
    December 23, 1985
    Decision Date
    February 18, 1986
    Product Code
    LLO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLO Laser, Neodymium:Yag, Pulmonary Surgery

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