Device |
over-the-counter radiofrequency coagulation device for wrinkle reduction |
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. |
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 Code | PAY |
Premarket Review |
Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4420
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |