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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K253795
Device Name MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Applicant
Menicon Co, Ltd.
21-19, Aoi 3, Naka-Ku
Nagoya,  JP 460-0006
Applicant Contact Kana Nagasaki
Correspondent
Andre Vision and Device Research
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received11/28/2025
Decision Date 08/13/2026
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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