| Device |
dermal cooling pack/vacuum/massager |
| Regulation Description |
Contact cooling system for aesthetic use. |
| Definition |
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas. |
| Physical State |
the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas. |
| Technical Method |
release of fat and lipids from adipocyte cells resulting in reduction in fat layer |
| Target Area |
areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OOK |
|---|
| 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 |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
