510(k) K180299

ACUVUE OASYS (senofilcon A) with Photochromic Additive by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K180299 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE OASYS (senofilcon A) with Photochromic Additive". The FDA issued a decision of Substantially Equivalent on April 10, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Johnson & Johnson Vision Care, Inc. has at least 10 other 510(k) clearances on record.