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510(k) Data Aggregation

    K Number
    K980292
    Device Name
    CATARACT LIQUEFRACTURE DEVICE
    Manufacturer
    ALCON LABORATORIES
    Date Cleared
    1998-05-19

    (113 days)

    Product Code
    MUS
    Regulation Number
    886.4670
    Why did this record match?
    Product Code :

    MUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract
    Device Description
    The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.
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