Cleared Traditional

Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

K151586 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Aug 2015
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K151586 is an FDA 510(k) clearance for the Eye Secret 55 UV Aspheric (Methafilcon A) 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 August 10, 2015, 60 days after receiving the submission on June 11, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K151586 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2015
Decision Date August 10, 2015
Days to Decision 60 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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