Cleared Traditional

SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS

K121201 · St. shine Optical Co., Ltd. · Ophthalmic
Oct 2012
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K121201 is an FDA 510(k) clearance for the SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by St. shine Optical Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on October 26, 2012, 190 days after receiving the submission on April 19, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K121201 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2012
Decision Date October 26, 2012
Days to Decision 190 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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