The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Nubody Skin Toning Device.
| Device ID | K171588 |
| 510k Number | K171588 |
| Device Name: | NuBODY Skin Toning Device |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company Dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081 |
| Contact | Donald Ellis |
| Correspondent | Donald Ellis Carol Cole Company Dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-07-31 |
| Summary: | summary |