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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 K252385
Device Name Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Applicant
Pegavision Corporation
2f-1, #5, Shing Yeh St., Guishan Dist.
Taoyuan City,  TW 33341
Applicant Contact Estela Lin
Correspondent
Pegavision Corporation
2f-1, #5, Shing Yeh St., Guishan Dist.
Taoyuan City,  TW 33341
Correspondent Contact Estela Lin
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/31/2025
Decision Date 03/13/2026
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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