Cleared Traditional

LenSx Laser System (8065998162)

K243896 · Alcon Laboratories, Inc. · Ophthalmic

Apr 2025

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K243896 is an FDA 510(k) clearance for the LenSx Laser System (8065998162), a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 28, 2025, 131 days after receiving the submission on December 18, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K243896 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2024
Decision Date	April 28, 2025
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OOE — Ophthalmic Femtosecond Laser
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4390
Definition	Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.