Cleared Traditional

SUS (STENFILCON A) CONTACT LENS

K131378 · CooperVision, Inc. · Ophthalmic
Aug 2013
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K131378 is an FDA 510(k) clearance for the SUS (STENFILCON A) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on August 30, 2013, 108 days after receiving the submission on May 14, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K131378 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2013
Decision Date August 30, 2013
Days to Decision 108 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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