510(k) K182247

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) by Vizionfocus, Inc. — Product Code LPL

K182247 is an FDA 510(k) premarket notification submitted by Vizionfocus, Inc. for the device "ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)". The FDA issued a decision of Substantially Equivalent on October 12, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Vizionfocus, Inc. has at least 4 other 510(k) clearances on record.