510(k) K925631

PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE by Chiron Intraoptics — Product Code HQC

K925631 is an FDA 510(k) premarket notification submitted by Chiron Intraoptics for the device "PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE". The FDA issued a decision of Substantially Equivalent on July 29, 1993. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Chiron Intraoptics has at least 3 other 510(k) clearances on record.