Cleared Traditional

Stellaris Elite vision enhancement system

K232084 · Bausch and Lomb · Ophthalmic

Feb 2024

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K232084 is an FDA 510(k) clearance for the Stellaris Elite vision enhancement system, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Bausch and Lomb (St. Louis, US). The FDA issued a Cleared decision on February 26, 2024, 228 days after receiving the submission on July 13, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K232084 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2023
Decision Date	February 26, 2024
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF