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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 K161124
Device Name EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
Applicant
Vision Science Co., Ltd.
7, Jain-Ro 7-Gil, Jian-Myeon
Gyeongsangbuk-Do,  KR 712852
Applicant Contact OH IN-WHAN
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact BRET ANDRE
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/21/2016
Decision Date 08/26/2016
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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