510(k) K080512

REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT by Metro Optics of Austin, Inc. — Product Code LPL

K080512 is an FDA 510(k) premarket notification submitted by Metro Optics of Austin, Inc. for the device "REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT". The FDA issued a decision of Substantially Equivalent on July 23, 2008. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Metro Optics of Austin, Inc. has at least 7 other 510(k) clearances on record.