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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 K254269
Device Name Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon 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 Lee Mina
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 Lee Mina
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/30/2025
Decision Date 03/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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