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

    MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE

    K Number: K871934 · Decision Mar 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    8
    Review Days
    311

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    Basic Information

    Device Name
    MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
    K Number
    K871934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lasermatic, Inc.
    Date Received
    May 19, 1987
    Decision Date
    March 25, 1988
    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 Lasermatic, Inc.

    K Number Device Name
    K903131 LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM
    K901638 MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
    K893529 COMBOLASER MODEL 5050
    K871875 MODEL 5050 SURGILASER FOR OB-GYN USE
    K871932 MODEL 5050 SURGILASER FOR UROLOGY USE
    K871933 MODEL 5050 SURGILASER FOR NEUROSURGERY USE
    K871876 MODEL 5050 SURGILASER FOR PULMONARY USE