510(k) K033136

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 by Innova Vision, Inc. — Product Code LPL

K033136 is an FDA 510(k) premarket notification submitted by Innova Vision, Inc. for the device "I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2". The FDA issued a decision of Substantially Equivalent on March 5, 2004. 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.