510(k) K083216

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES by Ciba Vision Corporation — Product Code LPL

K083216 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on April 14, 2009. 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.