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LenSx Laser System

by Alcon Lensx, Inc.

510(k) K120732

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120732 Date6 Sep 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1688-2016 FDA Class II initiated 14 Apr 2016 on shared 510(k) K120732

    Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Lenssx Laser System
510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LenSx Laser System is a femtosecond laser device categorized as a phacofragmentation unit, designed for ophthalmic procedures. It utilizes high-precision laser energy to perform automated incisions and cuts in ocular tissue, aiding in cataract surgery and other lens-related interventions. The system is specifically engineered to enhance surgical precision, automate challenging steps, and improve procedural outcomes by reducing manual intervention. Its applications include capsulotomy and lens fragmentation, contributing to more controlled and accurate surgical techniques.

This device is intended for use in sterile operating room settings by trained ophthalmic professionals. Supplied as a reusable instrument, it requires adherence to strict maintenance and sterilization protocols between uses. The LenSx Laser System holds an FDA 510K clearance, indicating it is substantially equivalent to a predicate device. It is designed for compatibility with MRI environments, ensuring safe operation within magnetic resonance imaging settings. Proper storage and handling are essential to preserve functionality and sterility as outlined in manufacturer guidelines.

Other devices from Alcon Lensx, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LenSx Laser System used for in cataract surgery?

    The LenSx Laser System is designed to perform automated incisions and lens fragmentation during cataract surgery. It uses high-precision femtosecond laser energy to create controlled capsulotomies and break the lens into smaller fragments, reducing the need for manual intervention and enhancing surgical precision. This helps streamline procedures like phacoemulsification while improving outcomes.

  • Is the LenSx Laser System reusable or single-use?

    The LenSx Laser System is a reusable instrument. It requires strict adherence to maintenance and sterilization protocols between uses to ensure safety and functionality. Proper cleaning, disinfection, and storage are critical to maintaining its performance and sterility in sterile operating room settings.

  • Can the LenSx Laser System be used in MRI environments?

    Yes, the LenSx Laser System is specifically designed for compatibility with MRI environments. This ensures safe operation within magnetic resonance imaging settings, making it versatile for use in facilities where both laser-assisted cataract surgery and MRI procedures are performed.

  • What are the key benefits of using the LenSx Laser System over traditional cataract surgery tools?

    The LenSx Laser System automates critical steps like capsulotomy and lens fragmentation, reducing reliance on manual techniques. This automation enhances precision, minimizes surgical errors, and can improve procedural consistency. Additionally, its laser-based approach may offer better control over incision depth and shape, contributing to more predictable outcomes in cataract surgery.

  • How should the LenSx Laser System be stored to maintain its functionality?

    The LenSx Laser System must be stored according to the manufacturer’s guidelines to preserve its functionality and sterility. This includes keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage also involves following the recommended protocols for cleaning, disinfection, and maintenance to ensure it remains ready for use in sterile operating room conditions.