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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phototherapy device for reducing the appearance of acute post-surgical incisions
Definition This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.
Product CodeQPE
Regulation Number 878.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
KLOX TECHNLOGIES, INC.
  GRANTED 1

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