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    K Number
    K242924
    Device Name
    OPXION Optical Skin Viewer (OPXSV1-01F)
    Manufacturer
    OPXION Technology Inc.
    Date Cleared
    2025-06-23

    (272 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPXION Technology Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPXION Optical Skin Viewer is a non-invasive imaging system intended to be used for real-time visualization of the external tissues of the human body. The two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures can be obtained.
    Device Description
    OPXION Optical Skin Viewer is composed of two parts consisting of a handheld probe and a mainframe, connected by an optical fiber cable. The device comes with three accessories: a USB 3.0 cable, a power adapter, and a power cord. The Optical Skin Viewer needs to be connected to a laptop or a personal computer. The device uses Optical Coherence Tomography (OCT) technology with a Superluminescent diode, 840 nm, 6 mW light source.
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