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

    OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO

    K Number: K861173 · Decision Jul 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    58
    Review Days
    119

    Basic Information

    Device Name
    OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
    K Number
    K861173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    TRIMEDYNE, INC.
    Date Received
    March 28, 1986
    Decision Date
    July 25, 1986
    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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