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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 K260507
Device Name Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
Applicant
INTEROJO, Inc.
28& 25 Sandan-Ro 15 Beon-Gil
Pyeongtaek-Si,  KR 459040
Applicant Contact Youngkyun Kim
Correspondent
Andre Vision and Device Research
3762 Landis St.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/17/2026
Decision Date 05/29/2026
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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