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510(k) Data Aggregation
K Number
K022833Device Name
BENJAMIN ENVOY PHACO HANDPIECE
Manufacturer
Date Cleared
2002-09-09
(14 days)
Product Code
Regulation Number
886.4670Why 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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