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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 K232839
Device Name Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
Applicant
Yung Sheng Optical Co., Ltd.
#8, Keya 2nd Rd., Daya District
Taichung City,  TW 42881
Applicant Contact Wen-Han Chen
Correspondent
Yung Sheng Optical Co., Ltd.
#8, Keya 2nd Rd., Daya District
Taichung City,  TW 42881
Correspondent Contact Wen-Han Chen
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/14/2023
Decision Date 12/16/2024
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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