Cleared Traditional

BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,

K131208 · Bausch & Lomb, Inc. · Ophthalmic
Sep 2013
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K131208 is an FDA 510(k) clearance for the BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on September 11, 2013, 135 days after receiving the submission on April 29, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K131208 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2013
Decision Date September 11, 2013
Days to Decision 135 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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