510(k) K243953

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

K243953 is an FDA 510(k) premarket notification submitted by Vizionfocus, Inc. for the device "Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)". The FDA issued a decision of Substantially Equivalent on Apr 10, 2025. 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.