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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K180819
Device Name One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
Applicant
Menicon Co, Ltd.
21-19, Aoi 3, Naka-Ku
Nagoya,  JP 460-0006
Applicant Contact Kenichi Tanaka
Correspondent
Foresight Regulatory Strategies, Inc.
187 Ballardvale St.
Suite 250
Wilmington,  MA  01887
Correspondent Contact Ellen M. Beucler
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/29/2018
Decision Date 05/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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