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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light based treatment for cold sores herpes simplex virus-1
Regulation Description Light based energy source device for topical application.
Definition Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Product CodeOKJ
Regulation Number 878.4860
Device Class 2


Premarket Reviews
ManufacturerDecision
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 1
LUMINANCE MEDICAL VENTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NUON MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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