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510(k) Data Aggregation

    K Number
    K022833
    Device Name
    BENJAMIN ENVOY PHACO HANDPIECE
    Date Cleared
    2002-09-09

    (14 days)

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

    BENJAMIN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.
    Device Description
    1. General: The handpiece uses a piezoelectric transduction method to longitudinally oscillate a cutting tip (not included with the device) at a resonant frequency of 28 kHz. The device has integral colinear irrigation and coaxial aspiration fluidic pathways. 2. Host Phacofragmentation System: The device is intended as a replacement for the phacofragmentation handpiece used on the Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles. These systems has been commercially available in the U.S. for approximately 10 years. To insure compatibility with the host system, the Envoy handpiece is designed to be equivalent to the original handpiece used on the previously mentioned systems.
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