510(k) K151918

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist by Bausch & Lomb, Incorporated — Product Code LPL

K151918 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist". The FDA issued a decision of Substantially Equivalent on February 11, 2016. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Bausch & Lomb, Incorporated has at least 10 other 510(k) clearances on record.