Cleared Special

MyDay

K190965 · CooperVision, Inc. · Ophthalmic
Apr 2019
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K190965 is an FDA 510(k) clearance for the MyDay, 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 April 29, 2019, 17 days after receiving the submission on April 12, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K190965 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2019
Decision Date April 29, 2019
Days to Decision 17 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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