Cleared Special

LenSx Laser System (8065000944)

K252682 · Alcon Laboratories, Inc. · Ophthalmic

Sep 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K252682 is an FDA 510(k) clearance for the LenSx Laser System (8065000944), 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 September 24, 2025, 30 days after receiving the submission on August 25, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K252682 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2025
Decision Date	September 24, 2025
Days to Decision	30 days
Submission Type	Special
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.