| Device |
light based over the counter wrinkle reduction |
| Regulation Description |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Definition |
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided. |
| Physical State |
The device can be hand held or mounted on a support system like a stand or mechanical arm. The device will emit light that can be monochromatic or narrow band or broad band. The light energy may be very low to moderate power levels. |
| Technical Method |
Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles. |
| Target Area |
Mostly intended to be used on the human face, head, and neck. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OHS |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4810
|
|---|
| 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
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
