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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 K262495
Device Name Miru 1day UpSide (midafilcon A)
Applicant
Menicon Co, Ltd.
21-19, Aoi 3, Naka-Ku
Nagoya,  JP 460-0006
Applicant Contact Kana Nagasaki
Correspondent
Andre Vision and Device Research
3762 Landis St.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/20/2026
Decision Date 09/17/2026
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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