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510(k) Data Aggregation

    K Number
    K082850
    Device Name
    EYE SPHERES
    Manufacturer
    PRODUCT AND EDUCATIONAL SERVICES LLC
    Date Cleared
    2009-02-27

    (151 days)

    Product Code
    HPZ, HQN
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRODUCT AND EDUCATIONAL SERVICES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration) Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process
    Device Description
    When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.
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