K192077 is an FDA 510(k) clearance for the Tua Face Fitness / Tua Trend Face. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Vupiesse S.R.L (Rimini Rn, IT). The FDA issued a Cleared decision on September 30, 2020, 425 days after receiving the submission on August 2, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K192077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2019 |
| Decision Date | September 30, 2020 |
| Days to Decision | 425 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 |