510(k) K111697

AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM by Abbott Medical Optics, Inc. — Product Code HQC

K111697 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 2011. 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.