| Device |
low power electrosurgical devices for skin lesion destruction |
| Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
| Definition |
For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions |
| Physical State |
Electrosurgical cutting and coagulation device and accessories with a maximum output power of 5 Watts or Less |
| Technical Method |
The devices generates electrical arc in the ambient air between an electrical probe tip and the skin, which will cause intended tissue damage for the removal and destruction of skin lesions. |
| Target Area |
Skin |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QVJ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4400
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
