K162450 is an FDA 510(k) clearance for the ESPADA Acne-Clearing Blue Light Pen. This device is classified as a Over-the-counter Powered Light Based Laser For Acne (Class II - Special Controls, product code OLP).
Submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on November 30, 2016, 90 days after receiving the submission on September 1, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. 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..
| 510(k) Number | K162450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2016 |
| Decision Date | November 30, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | OLP - Over-the-counter Powered Light Based Laser For Acne |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| 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. |