Cleared Traditional

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

K021295 · St. shine Optical Co., Ltd. · Ophthalmic
Jun 2002
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K021295 is an FDA 510(k) clearance for the SAVIEW TORIC 55 (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 June 4, 2002, 41 days after receiving the submission on April 24, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K021295 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2002
Decision Date June 04, 2002
Days to Decision 41 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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