Cleared Traditional

LENSAR LASER SYSTEM

K090633 · Lensar, Inc. · Ophthalmic

May 2010

Decision

430d

Days

Class 2

Risk

About This 510(k) Submission

K090633 is an FDA 510(k) clearance for the LENSAR LASER SYSTEM, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Lensar, Inc. (Winter Park, US). The FDA issued a Cleared decision on May 13, 2010, 430 days after receiving the submission on March 9, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K090633 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2009
Decision Date	May 13, 2010
Days to Decision	430 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.