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

    OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL

    K Number: K870505 · Decision Aug 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    58
    Review Days
    184

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    Basic Information

    Device Name
    OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
    K Number
    K870505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Trimedyne, Inc.
    Date Received
    February 4, 1987
    Decision Date
    August 7, 1987
    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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