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510(k) Data Aggregation

    K Number
    K964289
    Device Name
    EYE FIXATION SPECULUM
    Manufacturer
    EYEFIX, INC.
    Date Cleared
    1996-12-17

    (50 days)

    Product Code
    HNC
    Regulation Number
    886.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    EYEFIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.
    Device Description
    The Eye Fixation Speculum, by eyeFix, Inc., consists of a low profile scleral vacuum ring attached to a medical quality plastic ophthalmic speculum using a six-degrees of freedom resistance joint. After retracting the eyelids, and securing the speculum, the vacuum ring is attached to the sclera by locating the medical quality concentric elastomer-ring to the cornea. Vacuum is applied by way of the attached spring-loaded syringe. When vacuum is applied, the flexible elastomer portion of the ring sucks down on the scleral region of the eye securing the ring to the eye. The frictional forces within the resistance joint of the attaching arm of the speculum, together with the vacuum ring, hold the eye steady against the tendency of the eye muscles to the move the globe. Although this resistance is high enough to prevent the eye from moving, the force is not so high that the physician is prevented from conveniently moving the ring within the range of motion that the joint allows. Luminescent plastic on the upper portion of the ring helps in visualization of the eye under low examination lighting.
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