K214103 is an FDA 510(k) clearance for the Shani Darden LED light therapy mask. This device is classified as a Over-the-counter Powered Light Based Laser For Acne (Class II - Special Controls, product code OLP).
Submitted by Harpar Grace International (Andover, GB). The FDA issued a Cleared decision on March 22, 2022, 83 days after receiving the submission on December 29, 2021.
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 | K214103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2021 |
| Decision Date | March 22, 2022 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |