Cleared Traditional

Faros Surgical System

K233398 · Oertli Instrumente AG · Ophthalmic

Jun 2024

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K233398 is an FDA 510(k) clearance for the Faros Surgical System, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Oertli Instrumente AG (Berneck, CH). The FDA issued a Cleared decision on June 27, 2024, 268 days after receiving the submission on October 3, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K233398 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2023
Decision Date	June 27, 2024
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF