510(k) K112373

CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION by Innova Vision, Inc. — Product Code LPL

K112373 is an FDA 510(k) premarket notification submitted by Innova Vision, Inc. for the device "CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION". The FDA issued a decision of Substantially Equivalent on August 17, 2012. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Innova Vision, Inc. has at least 10 other 510(k) clearances on record.