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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 Over-the-counter treatment of wrinkles and rhytides.
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 Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4420
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible