510(k) K100349

VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K100349 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER". The FDA issued a decision of Substantially Equivalent on May 21, 2010. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Johnson & Johnson Vision Care, Inc. has at least 10 other 510(k) clearances on record.