Cleared Traditional

ONE DAY FLAT PACK

K102895 · Menicon Co, Ltd. · Ophthalmic
Apr 2011
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K102895 is an FDA 510(k) clearance for the ONE DAY FLAT PACK, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Menicon Co, Ltd. (Grand Junction, US). The FDA issued a Cleared decision on April 28, 2011, 210 days after receiving the submission on September 30, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K102895 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2010
Decision Date April 28, 2011
Days to Decision 210 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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