510(k) K133115

COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK by Abbott Medical Optics, Inc. — Product Code HQC

K133115 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK". The FDA issued a decision of Substantially Equivalent on February 27, 2014. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Abbott Medical Optics, Inc. has at least 10 other 510(k) clearances on record.