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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 the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is Lensar, Inc.. The 510(k) number is K182795.

When did LENSAR Laser System - fs 3D (LLS-fs 3D) receive FDA 510(k) clearance?

LENSAR Laser System - fs 3D (LLS-fs 3D) received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182795.

Who is the listed applicant for LENSAR Laser System - fs 3D (LLS-fs 3D)?

The FDA 510(k) record lists Lensar, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Lensar, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220259ALLY Adaptive Cataract Treatment SystemK181430LENSAR Laser System - fs 3D (LLS-fs 3D)K173346LENSAR Laser System - fs 3D (LLS-fs 3D)K171337LENSAR Laser System – fs 3D (LLS-fs 3D)K170576LENSAR Laser System - fs 3D (LLS-fs 3D)

Related Devices (Code: OOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLCK220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

Official Source

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

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