Search Results

The RAICO Phacoemulsification Tip is used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments. The RAICO Irrigation Sleeve is intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. The RAICO Phacoemulsification Tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Phacoemulsification is a common practice in modern cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye. The ultrasonic handpiece is connected to, and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract." The primary device that is the subject of this 510(k) is a "Phacoemulsification Tip" (or "Phaco Tip") that is connected to the ultrasonic phacoemulsification handpiece. The Phacoemulsification Tip vibrates at an ultrasonic frequency, powered by the handpiece and surgical system, and thus emulsifies the cataract. The fragmented tissue is then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution is used to irrigate the eye and this is passed with the help of an "Irrigation Sleeve", a small molded component that is placed over the Phacoemulsification Tip. The RAICO Phacoemulsification Tip is packaged with a RAICO Irrigation Sleeve. The RAICO Phacoemulsification Tip and RAICO Irrigation Sleeve are made of medical grade titanium and silicone, respectively. In addition, test chamber and wrench accessories are included in the package and all of the devices and accessories will be sterilized, labeled and intended for single use only.