510(k) K232139

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens by Innova Vision, Inc. — Product Code LPL

K232139 is an FDA 510(k) premarket notification submitted by Innova Vision, Inc. for the device "Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on November 16, 2023. 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.