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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 K253885
Device Name PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES
Applicant
GEO MEDICAL CO., LTD.
7, Cheomdanyeonsin-Ro 398beon-Gil
Buk-Gu,  KR 61088
Applicant Contact Young Joon Park
Correspondent
Andre Vision and Device Research
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/04/2025
Decision Date 04/29/2026
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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