Cleared Traditional

SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K092852 · St. shine Optical Co., Ltd. · Ophthalmic
Mar 2010
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K092852 is an FDA 510(k) clearance for the SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, 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 March 11, 2010, 176 days after receiving the submission on September 16, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K092852 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2009
Decision Date March 11, 2010
Days to Decision 176 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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