K201906 is an FDA 510(k) clearance for the Trinity ELE Plus and Trinity ELE Plus Pro. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Carol Cole Company Dba Nuface (Vista, US). The FDA issued a Cleared decision on February 24, 2021, 230 days after receiving the submission on July 9, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K201906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2020 |
| Decision Date | February 24, 2021 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |