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
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.4410
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power measurement -- Radiation force balances and performance requirements

Guidance Documents

• Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Low Energy Ultrasound Wound Cleaner

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

• Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner; Availability

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc