510(k) K192005

Bausch + Lomb PreVue Inserter for enVista Preloaded by Bausch & Lomb, Inc. — Product Code MSS

K192005 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "Bausch + Lomb PreVue Inserter for enVista Preloaded". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.