Cleared Traditional

SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

K020917 · St. shine Optical Co., Ltd. · Ophthalmic
May 2002
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K020917 is an FDA 510(k) clearance for the SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by St. shine Optical Co., Ltd. (Littleton, US). The FDA issued a Cleared decision on May 6, 2002, 46 days after receiving the submission on March 21, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K020917 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2002
Decision Date May 06, 2002
Days to Decision 46 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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