Cleared Traditional

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

K240169 · Bausch and Lomb, Incorporated · Ophthalmic

Jul 2024

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K240169 is an FDA 510(k) clearance for the Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455), a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Bausch and Lomb, Incorporated (St. Louis, US). The FDA issued a Cleared decision on July 26, 2024, 186 days after receiving the submission on January 22, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K240169 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2024
Decision Date	July 26, 2024
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF