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

    PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T

    K Number: K854471 · Decision Feb 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    12
    Review Days
    99

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    Basic Information

    Device Name
    PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
    K Number
    K854471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Minnesota Laser Corp.
    Date Received
    November 6, 1985
    Decision Date
    February 13, 1986
    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 Minnesota Laser Corp.

    K Number Device Name
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    K854473 PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC
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    K854469 PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
    K854470 PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
    K852694 PORTALASE 200 CARBON SURGICAL LASER SYSTEM
    K852696 FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY
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