Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
PAY · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4420
Classification
FDA Product Code
PAY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4420
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.