Cleared Traditional

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens

K160803 · CooperVision, Inc. · Ophthalmic
Jul 2016
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K160803 is an FDA 510(k) clearance for the Avaira Vitality (fanfilcon A) Soft (Hydrofilic) 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 July 13, 2016, 112 days after receiving the submission on March 23, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K160803 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2016
Decision Date July 13, 2016
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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