Cleared Traditional

EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K132854 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Dec 2013
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K132854 is an FDA 510(k) clearance for the EYE SECRET 38 UV ASPHERIC (POLYMACON) 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 December 23, 2013, 102 days after receiving the submission on September 12, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K132854 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2013
Decision Date December 23, 2013
Days to Decision 102 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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