| Device |
powered surgical instrument for improvement in the appearance of cellulite |
| Regulation Description |
Powered surgical instrument for improvement in the appearance of cellulite. |
| Definition |
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite. |
| Physical State |
The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples. |
| Technical Method |
The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples. |
| Target Area |
Area with Cellulite, Fibrous Septae, Fat, Soft Tissue. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OUP |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4790
|
|---|
| 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 |
