510(k) K112302

PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES by CooperVision, Inc. — Product Code LPL

K112302 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on December 21, 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.