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510(k) Data Aggregation

    K Number
    K112952
    Device Name
    ILWAIT TIMER OCULOPRESSOR
    Date Cleared
    2012-05-10

    (218 days)

    Product Code
    Regulation Number
    886.4610
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORYX MEDICAL PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ilwait timer oculopressor device is used to perform pre-operative ocular compression. The device is used in the clinical and pre-operative ward, when the patient is supine, sedated and accompanied by a medical staff member. The mass of the ilwait timer oculopressor provides even pressure across the eyelid to soften the eye. The timer function provides a reminder to monitor the compression duration.
    Device Description
    The ilwait timer oculopressor is an orbital ocular compression applicator comprising a mass which applies a suitable force under gravity against the closed eyelid of a supine patient for the purpose of performing pre-operative ocular compression. The static pressure applied by the device assists in the diffusion of anaesthetic agents that may accumulate or be resident under the conjunctival membrane (chemosis) and surrounding tissues following retrobulbar, peribulbar and subtenons anaesthetic administration, and softens the eye by forcing intraocular fluid from the globe via the natural pressure regulation pathways. The ilwait timer oculopressor is located to the patient's head with an adjustable strap fitted to provide access to the left or right eye socket. The fixation of the device to this strap allows a static, balanced device position to be maintained. The ilwait timer oculopressor incorporates a user-activated cumulative stopwatch timer to record total duration of application, with an upper limit (including programmed pauses) indicated by a visual and audible interface warning at 23 minutes.
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