Cleared Traditional

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

K171337 · Lensar, Inc. · Ophthalmic

Aug 2017

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K171337 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 August 10, 2017, 94 days after receiving the submission on May 8, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K171337 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2017
Decision Date	August 10, 2017
Days to Decision	94 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.