|
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. |
Product Code | OLP |
Regulation Number |
878.4810
|
Device Class |
2
|
|
|
|