Cleared Traditional

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

K102727 · Lensar, Inc. · Ophthalmic

Mar 2011

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K102727 is an FDA 510(k) clearance for the LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY, 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 16, 2011, 175 days after receiving the submission on September 22, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K102727 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2010
Decision Date	March 16, 2011
Days to Decision	175 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.