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

    SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE

    K Number: K875104 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
    K Number
    K875104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Laserguide
    Date Received
    December 18, 1987
    Decision Date
    February 2, 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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    Other Clearances by Laserguide

    K Number Device Name
    K880071 SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
    K873892 SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE
    K873664 LIGHT-SPOT FIBEROPTIC LASER HANDPIECE
    K873571 LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE