The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Nuface Fix Skin Toning Device.
| Device ID | K182424 |
| 510k Number | K182424 |
| Device Name: | NuFACE FIX 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 | 2018-09-06 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858398007626 | K182424 | 000 |