510(k) K974469

MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL by Mentor Corp. — Product Code HQC

K974469 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Mentor Corp. has at least 10 other 510(k) clearances on record.