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

    PETRUS SINGLE MIRROR LASER LENS

    K Number: K862869 · Decision Aug 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    50
    Review Days
    23

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    Basic Information

    Device Name
    PETRUS SINGLE MIRROR LASER LENS
    K Number
    K862869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ocular Instruments, Inc.
    Date Received
    July 29, 1986
    Decision Date
    August 21, 1986
    Product Code
    LQJ
    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
    LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

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