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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound cleaner, ultrasound
Regulation Description Low energy ultrasound wound cleaner.
Definition The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound
Product CodeNRB
Regulation Number 878.4410
Device Class 2


Premarket Reviews
ManufacturerDecision
AROBELLA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CELLERATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

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