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

    ILUMIEN OPTIS

    K Number: K150878 · Decision Jul 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    105

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    Basic Information

    Device Name
    ILUMIEN OPTIS
    K Number
    K150878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lightlab Imaging, Inc.
    Date Received
    April 1, 2015
    Decision Date
    July 15, 2015
    Product Code
    NQQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NQQ System, Imaging, Optical Coherence Tomography (Oct)

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    Other Clearances by Lightlab Imaging, Inc.

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    K111201 C7 XR IMAGING SYSTEM
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