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U.S. Department of Health and Human Services

Product Classification
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Device skin patch for treatment of hyperhidrosis
Definition A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.
Physical State Topical patch.
Technical Method A topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis
Target Area Skin
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQVX
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4425
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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