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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 based device for dry age-related macular degeneration
De Novo Number DEN230083
Device Name Valeda Light Delivery System
Requester
lumithera, inc.
19578 10th ave. ne
ste 200
poulsbo,  WA  98370
Contact lori holder
Regulation Number886.5520
Classification Product Code
SDE  
Date Received12/14/2023
Decision Date 11/04/2024
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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