Cleared Traditional

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS

K132715 · Bausch & Lomb, Incorporated · Ophthalmic
Dec 2013
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K132715 is an FDA 510(k) clearance for the BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (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 December 20, 2013, 112 days after receiving the submission on August 30, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K132715 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2013
Decision Date December 20, 2013
Days to Decision 112 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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