Cleared Traditional

TBD

K123859 · Lensar, Inc. · Ophthalmic

Mar 2013

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K123859 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 March 27, 2013, 103 days after receiving the submission on December 14, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K123859 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2012
Decision Date	March 27, 2013
Days to Decision	103 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.