The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Nuface Mini Device.
| Device ID | K191672 |
| 510k Number | K191672 |
| Device Name: | NuFACE Mini Device |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company Dba NuFACE 1325 Sycamore Avenue, Suite A Vista, CA 92081 |
| Contact | Nadia Vazirzadeh Miller |
| Correspondent | Nadia Vazirzadeh Miller Carol Cole Company Dba NuFACE 1325 Sycamore Avenue, 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 | 2019-06-24 |
| Decision Date | 2019-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019720426 | K191672 | 000 |
| 00850019720327 | K191672 | 000 |
| 00850004079843 | K191672 | 000 |
| 00850004079836 | K191672 | 000 |
| 00850004079744 | K191672 | 000 |
| 00810075940121 | K191672 | 000 |