| Device |
contact cooling for skin lesion pain relief |
| Regulation Description |
Contact cooling system for aesthetic use. |
| Definition |
For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. |
| Physical State |
Surface contact cooling is achieved with an integrated conductive plate on skin, to lower the temperature of the skin. |
| Technical Method |
Regulate skin temperature through surface contact. |
| Target Area |
Body surface that needs skin lesion treatment in dermatological procedures, or temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QPZ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4340
|
|---|
| 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 |
