Cleared Traditional

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

K182795 · Lensar, Inc. · Ophthalmic

Dec 2018

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K182795 is an FDA 510(k) clearance for the LENSAR Laser System - fs 3D (LLS-fs 3D), a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on December 21, 2018, 81 days after receiving the submission on October 1, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K182795 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2018
Decision Date	December 21, 2018
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OOE — Ophthalmic Femtosecond Laser
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4390
Definition	Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.