Cleared Special

K252682 - LenSx Laser System (8065000944)

K252682 is an FDA 510(k) clearance for LenSx Laser System (8065000944), manufactured by Alcon Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Special 510(k) pathway after a 30-day FDA review.

K252682 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
30d
Days
Class 2
Risk

K252682 is an FDA 510(k) clearance for the LenSx Laser System (8065000944). Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 24, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K252682

510(k) Number K252682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OOE Device Classification - Class 2, Special Controls

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K252682.
LenSx Laser System (8065998162)
K243896 · Alcon Laboratories, Inc. · Apr 2025
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566 · Johnson & Johnson Surgical Vision, Inc. · Apr 2023
Catalys™ Precision Laser System
K223838 · Amo Manufacturing USA, LLC · Apr 2023
ALLY Adaptive Cataract Treatment System
K220259 · Lensar, Inc. · Jun 2022
CATALYS Precision Laser system
K220516 · Amo Manufacturing USA, LLC · May 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · Sie Ag,Surgical Instrument Engineering · Apr 2022
K252682 · LenSx Laser System (8065000944)
Download PDF FDA Summary Alcon Laboratories, I…