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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autofluorescence imaging adjunct tool for wounds
Regulation Description Autofluorescence detection device for general surgery and dermatological use.
Definition An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Product CodeQJF
Regulation Number 878.4550
Device Class 2


Premarket Reviews
ManufacturerDecision
KENT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOLECULIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRECISION HEALING, LLC
  SUBSTANTIALLY EQUIVALENT 1
SWIFT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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