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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 digital therapy device for amblyopia
De Novo Number DEN210005
Device Name Luminopia One
Luminopia, Inc.
955 massachusetts ave #335
cambridge,  MA  02139
Contact scott xiao
Regulation Number886.5500
Classification Product Code
Date Received03/01/2021
Decision Date 10/20/2021
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct