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Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

FDA product code PAY · 11 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4420
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-06-15 – 2026-01-06

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.

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