Cleared Traditional

EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K133735 · Yung Sheng Optical Co., Ltd. · Ophthalmic
Mar 2014
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K133735 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 March 21, 2014, 102 days after receiving the submission on December 9, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K133735 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2013
Decision Date March 21, 2014
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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