Cleared Traditional

TBD

K112098 · Lensar, Inc. · Ophthalmic

Oct 2011

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K112098 is an FDA 510(k) clearance for the TBD, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on October 19, 2011, 89 days after receiving the submission on July 22, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K112098 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2011
Decision Date	October 19, 2011
Days to Decision	89 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.