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510(k) Data Aggregation
K Number
K051186Device Name
MICROPULSE PHACOEMULSIFICATION SYSTEM
Manufacturer
Date Cleared
2005-08-18
(101 days)
Product Code
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
TRILLIUM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Phacoemulsification/extraction with ultrasonic power of cataractous lens from the eye.
Device Description
The MicroPulse Phacoemulsification Console and foot switch, with third party accessories, will emulsify a cataractous lens and remove it from the eye, using the same technology that the predicate devices employ by using ultrasonic power. The MicroPulse Phacoemulsification Console modes of operation are similar to the predicate devices such as: Diathermy (Coagulation), U/S Phaco, Irrigation/Aspiration (I/A) and Vitrectomy. The component parts of the MicroPulse Phacoemulsification console include the console and foot switch. The U/S handpiece and tubing set are specified third party accessories. The Diathermy, Irrigation/ Aspiration, and Vitrectomy devices are universal type handpieces that are also considered additional third party accessories to the MicroPulse Phacoemulsification console. Trillium Medical will manufacture the console and foot switch only. Trilliums Distributers will add the third party accessories (see Exhibit B) to the console and foot switch to assemble a complete Phacoemulsification system.
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