Product Classification

• 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 Code: OUB
• 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 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
• smo india
• third party review group, llc