Product Classification

• Device: ultrasound, skin permeation
• Regulation Description: Low energy ultrasound wound cleaner.
• Definition: Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NRJ
• 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: Ineligible
• 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

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