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U.S. Department of Health and Human Services

Product Classification

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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 CodePBX
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons