510(k) K242389

EyeGility™ Inserter for Preloaded enVista IOLs by Bausch & Lomb, Incorporated — Product Code MSS

K242389 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "EyeGility™ Inserter for Preloaded enVista IOLs". The FDA issued a decision of Substantially Equivalent on October 10, 2024. 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, Incorporated has at least 10 other 510(k) clearances on record.