Cleared Traditional

Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens

K143052 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Dec 2014
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K143052 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens, 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 December 16, 2014, 54 days after receiving the submission on October 23, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K143052 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2014
Decision Date December 16, 2014
Days to Decision 54 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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