K213039 is an FDA 510(k) clearance for the Micro-current facial cold and hot service (model: TPML-100). This device is classified as a Over-the-counter Powered Light Based Laser For Acne (Class II - Special Controls, product code OLP).
Submitted by Li-Tek Electronics Technology C0., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on May 25, 2022, 245 days after receiving the submission on September 22, 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 | K213039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2021 |
| Decision Date | May 25, 2022 |
| Days to Decision | 245 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. |