510(k) K062614

VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K062614 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)". The FDA issued a decision of Substantially Equivalent on November 1, 2006. 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.