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510(k) Data Aggregation

    K Number
    K170655
    Device Name
    Zepto
    Manufacturer
    Mynosys Cellular Devices, Inc.
    Date Cleared
    2017-06-02

    (91 days)

    Product Code
    PUL
    Regulation Number
    886.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mynosys Cellular Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zepto™ is indicated for use in performing anterior capsulotomy during cataract surgery.
    Device Description
    The Zepto™ is an electrosurgical device indicated for use in performing anterior capsulotomies during cataract surgery. The Zepto™ Capsulotomy System consists of a console, disposable handpiece, and a fluid isolator assembly (consisting of the fluid isolator, roller dispenser, and clamp). The handpiece power cord connector is connected to the front panel of the console to provide power for the capsulotomy procedure. The medical grade PVC suction tubing from the handpiece is connected to the fluid isolator. The fluid isolator is then connected to the console's front panel to provide suction during the treatment to a silicone suction cup containing the capsulotomy element. The Zepto 110 console delivers pulsed DC energy from a storage capacitor to a circular capsulotomy element on the tip of the disposable handpiece for creation of a nominal 5mm diameter capsulotomy.
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