510(k) K252052

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) by Bausch and Lomb, Incorporated — Product Code HQC

K252052 is an FDA 510(k) premarket notification submitted by Bausch and Lomb, Incorporated for the device "Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)". The FDA issued a decision of Substantially Equivalent on March 25, 2026. 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.