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FDA 510(k)

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

K-Number: K171337 · 2017-08-10

ApplicantLensar, Inc.
Decision Date2017-08-10
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSAR Laser System – fs 3D (LLS-fs 3D) is a medical device manufactured by Lensar, Inc.. It received FDA 510(k) clearance on 2017-08-10 under approval number K171337. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENSAR Laser System – fs 3D (LLS-fs 3D)?

LENSAR Laser System – fs 3D (LLS-fs 3D) is a medical device that received FDA 510(k) clearance on 2017-08-10. It is manufactured by Lensar, Inc.. The 510(k) number is K171337.

When was LENSAR Laser System – fs 3D (LLS-fs 3D) approved by the FDA?

LENSAR Laser System – fs 3D (LLS-fs 3D) received FDA 510(k) clearance on 2017-08-10, under approval number K171337.

What company makes LENSAR Laser System – fs 3D (LLS-fs 3D)?

LENSAR Laser System – fs 3D (LLS-fs 3D) is manufactured by Lensar, Inc..

What is the FDA product code for LENSAR Laser System – fs 3D (LLS-fs 3D)?

The FDA product code for LENSAR Laser System – fs 3D (LLS-fs 3D) is OOE.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Lensar, Inc.

K170576LENSAR Laser System - fs 3D (LLS-fs 3D) K182795LENSAR Laser System - fs 3D (LLS-fs 3D) K181430LENSAR Laser System - fs 3D (LLS-fs 3D) K173346LENSAR Laser System - fs 3D (LLS-fs 3D) K220259ALLY Adaptive Cataract Treatment System

Related Devices (Code: OOE)

K161288LenSX Laser SystemAlcon Laboratories, Inc. K161455Catalys Precision Laser SystemOptimedica Corporation K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc. K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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