510(k) K111966

PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC by CooperVision, Inc. — Product Code LPL

K111966 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. CooperVision, Inc. has at least 10 other 510(k) clearances on record.