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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K251876
Device Name cleadew GP hydra one
Applicant
Ophtecs Corporation
5-2-4, Minatojima-Minamimachi, Chuo-Ku,
Kobe,  JP 650-0047
Applicant Contact Takeichi Ryohei
Correspondent
Andre Vision and Device Research
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5918
Classification Product Code
MRC  
Date Received06/18/2025
Decision Date 10/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT06626009
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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