Cleared Traditional

SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K030548 · St. shine Optical Co., Ltd. · Ophthalmic
Apr 2003
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K030548 is an FDA 510(k) clearance for the SAVIEW 55 MULTIFOCAL (METHAFILCON 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. (Felton, US). The FDA issued a Cleared decision on April 4, 2003, 43 days after receiving the submission on February 20, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K030548 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2003
Decision Date April 04, 2003
Days to Decision 43 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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