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510(k) Data Aggregation

    K Number
    K222484
    Device Name
    Retitrack
    Manufacturer
    C. Light Technologies, Inc.
    Date Cleared
    2023-05-09

    (265 days)

    Product Code
    HLL
    Regulation Number
    886.1510
    Why did this record match?
    Applicant Name (Manufacturer) :

    C. Light Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Retitrack™ is intended for recording, viewing, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician's office, clinic, laboratory).
    Device Description
    The Retitrack™ is a monocular, bench-top saccadometer that incorporates scanning laser ophthalmoscope (SLO) technology and eye tracking software to record, view, measure, and analyze eye motion. The Retitrack™ is comprised of an optical head containing an illumination system and an optical system; a base unit with a computer, electronics, and a power distribution system; connections for external input/output devices (e.g., monitor, keyboard, mouse, and storage media); a patient forehead and chin rest; and operational software. The Retitrack™ interacts with the patient by directing light from an infrared (840 nm) superluminescent diode (SLD) into the patient's eye. The only parts of the device that contact the patient are the forehead and chin rest with adjustable temple pads and an optional attachable head strap to stabilize the patient's head. The Retitrack™ uses the SLD light to scan the patient's retina in two dimensions while the patient is viewing a visual stimulus. The optical imaging system detects the reflected (or returned) light from the retina and creates high-resolution, digital retinal video sequences over time. The eye tracking software uses eye motion corrected frames to measure the translational retinal movement over time. The device displays the analysis of the eye motion results and saves the retinal video and a report. The Retitrack™ does not provide a diagnosis or treatment recommendation. The Retitrack™ has separate tests that measure fixation stability (including microsaccades and drift) and visually guided horizontal saccade tracking. The Retitrack™ can be programmed by the user with specific visual stimuli presentations, including a single fixed stimulus to measure fixation stability or two alternating stimuli in different orientations to measure horizontal saccades. For the fixation stability test, the Retitrack™ analyzes the fixation responses, including microsaccade amplitude, microsaccade frequency, microsaccade velocity, drift velocity, and drift ratio over time. For the saccade tracking tests, the Retitrack™ analyzes the saccadic responses, including duration, amplitude, target accuracy, latency, and velocity.
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