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U.S. Department of Health and Human Services

Product Classification

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Device over-the-counter radiofrequency coagulation device for wrinkle reduction
Regulation Description Electrosurgical device for over-the-counter aesthetic use.
Definition An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
Physical State Radiofrequency current generator and electrode applicators
Technical Method Radiofrequency electrical current (i.e., electrosurgical device)
Target Area skin wrinkles and rhytides
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePAY
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4420
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 Not Third Party Eligible