| Device |
over-the-counter powered light based laser for acne |
| Regulation Description |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Definition |
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris. |
| Physical State |
Light Source |
| Technical Method |
The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. |
| Target Area |
Mainly on the face, but can be on the back or on the other parts of the body. Treatment area is 5x6 cm (at a time.) |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OLP |
|---|
| 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 |
