Cleared Traditional

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

K213983 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Sep 2022
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K213983 is an FDA 510(k) clearance for the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on September 2, 2022, 256 days after receiving the submission on December 20, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K213983 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2021
Decision Date September 02, 2022
Days to Decision 256 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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