510(k) K950880

AOI UNIVERSAL ULTRASONIC HANDPIECE by American Optical Corp. — Product Code HQC

K950880 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "AOI UNIVERSAL ULTRASONIC HANDPIECE". The FDA issued a decision of Substantially Equivalent on May 26, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. American Optical Corp. has at least 10 other 510(k) clearances on record.