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FDA 510(k)

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

K-Number: K181430 · 2018-08-09

ApplicantLensar, Inc.
Decision Date2018-08-09
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 2018-08-09 under approval number K181430. 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 2018-08-09. It is manufactured by Lensar, Inc.. The 510(k) number is K181430.

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 2018-08-09, under approval number K181430.

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.

K171337LENSAR Laser System – fs 3D (LLS-fs 3D) K170576LENSAR Laser System - fs 3D (LLS-fs 3D) K182795LENSAR 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 K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. K170322Catalys Precision Laser SystemAbbott Medical Optics, 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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