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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K250495
Device Name MINI VP1 (PL67_F); MINI VP1 (PL61_F)
Applicant
Avizor S.A.
Avenida De La Innovación, 2, Parque Leganés Tecnológico
Leganés,  ES 28919
Applicant Contact Alberto Rodríguez
Correspondent
Avizor S.A.
Avenida De La Innovación, 2, Parque Leganés Tecnológico
Leganés,  ES 28919
Correspondent Contact María Salvador
Regulation Number886.5928
Classification Product Code
LRX  
Subsequent Product Code
LPN  
Date Received02/20/2025
Decision Date 08/01/2025
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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