FDA product code PAY

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

General, Plastic Surgery·Class 2·21 CFR 878.4420
US regulatory classifications
US Product Code (FDA)
PAY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4420
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.