510(k) K191933

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal by Johnson & Johnson Surgical Vision, Inc. — Product Code HQC

K191933 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Surgical Vision, Inc. for the device "COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal". The FDA issued a decision of Substantially Equivalent on August 16, 2019. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Johnson & Johnson Surgical Vision, Inc. has at least 3 other 510(k) clearances on record.