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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 phototherapy device for reducing the appearance of acute post-surgical incisions
De Novo Number DEN200005
Device Name Klox Biophotonic LumiHeal System
Requester
klox technlogies, inc.
275, boul. armand frappier
laval,  CA h7v 4a7
Contact daniela jukic
Regulation Number878.4880
Classification Product Code
QPE  
Date Received02/04/2020
Decision Date 12/03/2021
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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