510(k) K033919

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS by Ciba Vision Corporation — Product Code LPL

K033919 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.