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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intraoral phototherapy device
Definition An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis.
Product CodeSGQ
Regulation Number 872.5595
Device Class 2


Premarket Reviews
ManufacturerDecision
MUREVA PHOTOTHERAPY, INC.
  GRANTED 1

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