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

    MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE

    K Number: K844668 · Decision Jan 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    54
    Review Days
    34

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    Basic Information

    Device Name
    MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
    K Number
    K844668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    November 30, 1984
    Decision Date
    January 3, 1985
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic

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