Product Classification

• Device: massager, vacuum, radio frequency induced heat
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
• Physical State: A console that generates the RF energy. It has two handpieces, an RF handpiece to apply energy for the pain relief indication and a mechanical roller handpiece for the cellulite indication.
• Technical Method: Increases the temperature of skin by deposition of RF waves to relieve minor aches and pain. It uses a mechanical roller to reduce the appearance of cellulite.
• Target Area: Skin.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: PBX
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4400
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc