510(k) K061157

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS by Bausch & Lomb — Product Code MVN

K061157 is an FDA 510(k) premarket notification submitted by Bausch & Lomb for the device "SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS". The FDA issued a decision of Substantially Equivalent on June 22, 2006. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Bausch & Lomb has at least 10 other 510(k) clearances on record.