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U.S. Department of Health and Human Services

Product Classification

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Device instrument for treatment of hyperhidrosis
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Soft-tissue coagulation
Physical State The System consists of the following components: the Console; the Handpiece; and a disposable tip that snaps onto the Handpiece.
Technical Method microwave based system
Target Area dermal-hypodermal interface
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOUB
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