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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
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

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 1 1

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