510(k) K081865

PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR by CooperVision, Inc. — Product Code LPL

K081865 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR". The FDA issued a decision of Substantially Equivalent on September 29, 2008. 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.