BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇫🇮 Finland

    LASERMATIC SURGILASER MODEL 5050

    K Number: K870587 · Decision Aug 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    547

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    Basic Information

    Device Name
    LASERMATIC SURGILASER MODEL 5050
    K Number
    K870587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Lasermatic OY
    Date Received
    February 10, 1987
    Decision Date
    August 10, 1988
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWG Laser, Ent Microsurgical Carbon-Dioxide

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    Other Clearances by Lasermatic OY

    K Number Device Name
    K895279 LASERMATIC COMBOLASER MODEL 5050