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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 K242916
Device Name Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
Applicant
Largan Medical Co., Ltd.
2f., # 14, 23rd Rd., Taichung Industrial Park,
Nantun Dist.
Taichung,  TW 40850
Applicant Contact Shih-min Chen
Correspondent
Largan Medical Co., Ltd.
2f., # 14, 23rd Rd., Taichung Industrial Park,
Nantun Dist.
Taichung,  TW 40850
Correspondent Contact Shih-min Chen
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/24/2024
Decision Date 02/04/2025
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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