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510(k) Data Aggregation

    K Number
    K030957
    Device Name
    PERFECT CAPSULE
    Manufacturer
    MILVELLA PTY. LTD.
    Date Cleared
    2003-08-20

    (146 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILVELLA PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Milvella Perfect Capsule is intended to be used after phacoemulsification of the natural crystalline lens by providing a method for sealed capsule polishing and irrigation, for the purpose of removing residual cortex and/or epithelial cells. The Milvella Perfect Capsule is intended for use after phacoemulsification of the natural crystalline lens for the purpose of removing residual cortex and/or epithelial cells, by providing a method for sealed capsule polishing and irrigation.
    Device Description
    The Perfect Capsule is a single-use, sterile instrument molded from silicone and designed for use in cataract surgery for the purpose of removing residual cortex and/or epithelial cells after cataract extraction by phacoemulsification. This device provides a method of holding the empty lens capsule and containing irrigation fluid to within the lens capsule after cataract removal, thus reducing the risk of irrigating fluid contacting other ocular structures including the corneal endothelium.
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