510(k) K152046

Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) by Art Optical Contact Lens, Inc. — Product Code LPL

K152046 is an FDA 510(k) premarket notification submitted by Art Optical Contact Lens, Inc. for the device "Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)". The FDA issued a decision of Substantially Equivalent on November 24, 2015. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Art Optical Contact Lens, Inc. has at least 5 other 510(k) clearances on record.