Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K182795 · 2018-12-21

ApplicantLensar, Inc.
Decision Date2018-12-21
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 2018-12-21 under approval number K182795. 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 2018-12-21. It is manufactured by Lensar, Inc.. The 510(k) number is K182795.

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 2018-12-21, under approval number K182795.

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.

Related Clinical Trials

NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT06795451 Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains RECRUITING NCT07340671 Facial Papules in Frontal Fibrosing Alopecia (FFA) NOT_YET_RECRUITING

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) 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 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.

↑