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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNRB
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4410
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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