Product Classification

• 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 Code: NRB
• Submission Type: 510(k)
• Regulation Number: 878.4410
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• tuv sud america inc.
• underwriters laboratories, inc.