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LENSAR Laser System - fs 3D (LLS-fs 3D)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181430

by Lensar, Inc.

Identifiers

510(k) Number
K181430 FDA 510(k)
FDA Product Code
OOE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is an ophthalmic femtosecond laser system, specifically the LENSAR Laser System - fs 3D (LLS-fs 3D), designed for use in cataract surgery. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The system is supplied as a reusable laser platform intended for use in ophthalmic surgical settings. It operates under FDA regulation with product code OOE and regulation number 886.4390, and is manufactured by Lensar, Inc. in Orlando, Florida.

Frequently asked questions

What is the LENSAR Laser System - fs 3D used for?

The LENSAR Laser System - fs 3D is designed for use in cataract surgery as an ophthalmic femtosecond laser system, enabling precise laser-assisted procedures in ophthalmic surgical settings.

Is the LENSAR Laser System - fs 3D reusable or single-use?

The system is supplied as a reusable laser platform, meaning it is intended for multiple uses in ophthalmic surgical environments after appropriate cleaning and maintenance between procedures.

How was the LENSAR Laser System - fs 3D cleared for market?

The device received FDA 510(k) clearance through a traditional submission process, demonstrating substantial equivalence to a predicate device under product code OOE and regulation number 886.4390.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Femtosecond Laser System | LENSAR Inc., The LENSAR® Laser System–fs 3D for Femtosecond Cataract Surgery, LENSAR Robotic Cataract Laser System for Refractive Cataract Eye Surgeons, PDF You-Centric. Today and Tomorrow. - teleon-surgical.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lensar, Inc.

Sources (1)

  • FDA 510(k) K181430 24 fields · synced Sep 24, 2026