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510(k) Data Aggregation

    K Number
    K053333
    Device Name
    EAGLEVISION GELLANSERTS, MODEL REF 0040
    Manufacturer
    EAGLE VISION, INC.
    Date Cleared
    2006-05-02

    (152 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EAGLE VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EagleVision Gellansert is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Determine the potential effectiveness of permanent occlusion, - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Increase retention of ocular medications - Temporarily treat contact lens intolerance secondary to dry eye, and - Treat dry eye after surgery.
    Device Description
    EagleVision Gellanserts are intended to temporarily block tear drainage by occlusion of the canaliculus. EagleVision Gellanserts are made of a hydrophilic, resorbable material, and are designed to expand only laterally after insertion into the canaliculus, so that only one size is needed to occlude most patients' lacrimal systems. The EagleVision Gellanserts are designed to expand and fit virtually all patient anatomies from 0.3mm up to 1.1 mm, so multiple inserts in one canaliculus are generally not necessary. There are five inserts per sterile pouch, so that one EagleVision Gellansert can be placed in each punctum with one additional EagleVision Gellansert in case one is dropped or mishandled.
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    K Number
    K030353
    Device Name
    MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
    Manufacturer
    EAGLE VISION, INC.
    Date Cleared
    2003-04-25

    (81 days)

    Product Code
    OKS, HNL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EAGLE VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.
    Device Description
    The MonoStent™ Monocanalicular Stent, the EagleVision® Lacrimal Intubation Set, and the EagleVision® K Type Lacrimal Intubation Set are lacrimal stents and delivery systems. The MonoStent™ Monocanalicular Stents consist of a length of silicone tubing, with a silicone punctum pluq molded perpendicularly onto one end of the tubing. A stainless steel stylet is provided with the stent to assist in the insertion of the silicone tubing. The EagleVision® Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of medical grade silicone tubing that is attached to malleable stainless steel probes. The intubation set allows for probing and stenting as a one step procedure. The EagleVision® K Type Lacrimal Intubation Set is comprised of stents for use in monocanalicular and bicanalicular intubation procedures. The stents are made of silicone probes attached with a silicone rod.
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    K Number
    K991130
    Device Name
    FLEXPLUG
    Manufacturer
    EAGLE VISION, INC.
    Date Cleared
    1999-04-20

    (18 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EAGLE VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye.
    Device Description
    FlexPlug Punctum Plug
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