BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    INTEGRE PRO, MODEL L2RY

    K Number: K081565 · Decision Jul 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    INTEGRE PRO, MODEL L2RY
    K Number
    K081565
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ellex Medical Pty, Ltd.
    Date Received
    June 4, 2008
    Decision Date
    July 2, 2008
    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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    Other Clearances by Ellex Medical Pty, Ltd.

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    K122202 ELLEX 2RT
    K080423 INTEGRE, MODEL LP581
    K052777 LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
    K041598 LASEREX, MODEL LP4532
    K021550 LUMENIS SELECTA DUET
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