Cleared Special

MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens

K220070 · CooperVision, Inc. · Ophthalmic
Feb 2022
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K220070 is an FDA 510(k) clearance for the MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens, 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 February 4, 2022, 25 days after receiving the submission on January 10, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K220070 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2022
Decision Date February 04, 2022
Days to Decision 25 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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