510(k) K871938

VISION CARE/PHAKOSYSTEMS ECHORULE by Phakosystems, Inc. — Product Code IYO

K871938 is an FDA 510(k) premarket notification submitted by Phakosystems, Inc. for the device "VISION CARE/PHAKOSYSTEMS ECHORULE". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Phakosystems, Inc. has at least 4 other 510(k) clearances on record.