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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 K260311
Device Name Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV multifocal (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Applicant
St. shine Optical Co., Ltd.
4,5f # 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist.
New Taipei City,  TW 22146
Applicant Contact Mina Lee
Correspondent
St. shine Optical Co., Ltd.
4,5f # 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist.
New Taipei City,  TW 22146
Correspondent Contact Mina Lee
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received01/30/2026
Decision Date 10/28/2026
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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