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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 light attenuation lenses for migraine-associated light sensitivity
De Novo Number DEN250026
Device Name Avulux
Requester
matap ii, llc
18117 biscayne blvd.
suite 125
aventura,  FL  33160
Contact charles posternack
Regulation Number882.5811
Classification Product Code
QEO  
Date Received06/23/2025
Decision Date 08/21/2026
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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