Cleared Traditional

SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)

K132146 · St. shine Optical Co., Ltd. · Ophthalmic
Aug 2013
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K132146 is an FDA 510(k) clearance for the SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by St. shine Optical Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on August 30, 2013, 50 days after receiving the submission on July 11, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K132146 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2013
Decision Date August 30, 2013
Days to Decision 50 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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