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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 K253875
Device Name OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens
Applicant
Visco Vision, Inc.
# 1, Xingye St., Guishan Dist.,
Taoyuan City,  TW 33341
Applicant Contact Janice Yu
Correspondent
Visco Vision, Inc.
# 1, Xingye St., Guishan Dist.,
Taoyuan City,  TW 33341
Correspondent Contact Janice Yu
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/04/2025
Decision Date 10/23/2026
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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