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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 K242855
Device Name P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Applicant
E.O.S Co., Ltd.
188 Yuram-Ro, Dong-Gu
Daegu,  KR 41059
Applicant Contact Junghwa Choi
Correspondent
Wise Company, Inc.
#1107, #1108, 204, Gasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 08502
Correspondent Contact Sanglok Lee
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/20/2024
Decision Date 07/30/2025
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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