Cleared Special

Avaira Vitality

K213164 · CooperVision, Inc. · Ophthalmic
Oct 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K213164 is an FDA 510(k) clearance for the Avaira Vitality, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (San Ramon, US). The FDA issued a Cleared decision on October 26, 2021, 28 days after receiving the submission on September 28, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K213164 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date October 26, 2021
Days to Decision 28 days
Submission Type Special
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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