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

    MODEL 5050 SURGILASER FOR PULMONARY USE

    K Number: K871876 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    253

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    Basic Information

    Device Name
    MODEL 5050 SURGILASER FOR PULMONARY USE
    K Number
    K871876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Lasermatic, Inc.
    Date Received
    May 14, 1987
    Decision Date
    January 22, 1988
    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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    K893529 COMBOLASER MODEL 5050
    K871875 MODEL 5050 SURGILASER FOR OB-GYN USE
    K871932 MODEL 5050 SURGILASER FOR UROLOGY USE
    K871934 MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
    K871933 MODEL 5050 SURGILASER FOR NEUROSURGERY USE