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U.S. Department of Health and Human Services

Product Classification

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Device electrosurgical coagulation for aesthetic
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition For the treatment of spider vein or telangiectasia by thermocoagulation.
Physical State Electrosurgical generator and needle electrodes
Technical Method High Frequency radio wave energy
Target Area small surface blood vessels
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeONQ
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