Cleared Traditional

BAUSCH + LOMB NESOFILCON A CONTACT LENS

K113703 · Bausch & Lomb, Incorporated · Ophthalmic
Jun 2012
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K113703 is an FDA 510(k) clearance for the BAUSCH + LOMB NESOFILCON A CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on June 5, 2012, 172 days after receiving the submission on December 16, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K113703 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2011
Decision Date June 05, 2012
Days to Decision 172 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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