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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 K171157
Device Name PolyDev Soft Contact Lenses
Applicant
Polydev , Ltd.
Tinure Rd.
Collon,  IE
Applicant Contact John Mulvihill
Correspondent
Licensale, Inc.
68 Southwoods Ter.
Southbury,  CT  06488
Correspondent Contact Ray Kelly
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/20/2017
Decision Date 06/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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