Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4420
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
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.