The following data is part of a premarket notification filed by Carole Cole Company with the FDA for Nuface Mini Plus.
| Device ID | K201680 |
| 510k Number | K201680 |
| Device Name: | NuFACE Mini Plus |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carole Cole Company 1325 Sycamore Ave, Suite A Vista, CA 92081 |
| Contact | Danielle Barker Fernandes |
| Correspondent | Bob Duffy Carole Cole Company 1325 Sycamore Ave, Suite A Vista, CA 92081 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-02-19 |