510(k) K232084

Stellaris Elite vision enhancement system by Bausch and Lomb — Product Code HQC

K232084 is an FDA 510(k) premarket notification submitted by Bausch and Lomb for the device "Stellaris Elite vision enhancement system". The FDA issued a decision of Substantially Equivalent on February 26, 2024. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Bausch and Lomb has at least 10 other 510(k) clearances on record.