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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name prescription spectacle lenses to reduce the progression of myopia
De Novo Number DEN250016
Device Name Essilor® Stellest®
Requester
essilor of america, inc.
13455 branchview lane
dallas,  TX  75234
Contact john anderson
Regulation Number886.5845
Classification Product Code
QUR  
Date Received04/28/2025
Decision Date 09/25/2025
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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