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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 K153305
Device Name EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
Applicant
Eyeyon Medical
Golda Meir 5
Nes Ziona,  IL 7403649
Applicant Contact MALCA CHEN-ZION
Correspondent
Eyereg Consulting, Inc.
6119 Canter Lane
West Linn,  OR  97068
Correspondent Contact BRET ANDRE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received11/16/2015
Decision Date 04/08/2016
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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