| Device |
phototherapy device for reducing the appearance of acute post-surgical incisions |
| Definition |
This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics. |
| Physical State |
A light emitting LED lamp and a photoconverter gel. |
| Technical Method |
A blue light emitting LED lamp with light wavelengths at 440-460nm excites the chromophore inside the photocoverter gel to emit the fluorescent light with blue, green, yellow and orange light of wavelengths between 400nm to 625nm. The fluorescence light plus the excitation blue light are used for scar management. |
| Target Area |
Post surgical incisions. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QPE |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4880
|
|---|
| 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 |
