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510(k) Data Aggregation

    K Number
    K022836
    Device Name
    STEPHENS DISPOSABLE SPECULUM
    Manufacturer
    STEPHENS INSTRUMENTS
    Date Cleared
    2002-11-01

    (66 days)

    Product Code
    HNC
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
    Device Description
    A single use ophthalmic device designed to retract the eyelids.
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    K Number
    K981235
    Device Name
    OCULOSTAT
    Manufacturer
    LASER CENTER DEV. CORP.
    Date Cleared
    1998-07-15

    (103 days)

    Product Code
    HNC
    Regulation Number
    886.4350
    Why did this record match?
    Product Code :

    HNC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.
    Device Description
    The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
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    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?
    Product Code :

    HNC

    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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