510(k) K240169

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) by Bausch and Lomb, Incorporated — Product Code HQC

K240169 is an FDA 510(k) premarket notification submitted by Bausch and Lomb, Incorporated for the device "Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Bausch and Lomb, Incorporated has at least 10 other 510(k) clearances on record.