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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 wound autofluorescence imaging device
De Novo Number DEN180008
Device Name MolecuLight i:X
Requester
moleculight, inc.
101 college st., suite 200
toronto,  CA m5g1l7
Contact jeffrey k. shapiro
Regulation Number878.4165
Classification Product Code
QCR  
Date Received02/16/2018
Decision Date 07/31/2018
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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