The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Nuface Gel Primer.
| Device ID | K161654 |
| 510k Number | K161654 |
| Device Name: | NuFACE Gel Primer |
| Classification | Media, Electroconductive |
| Applicant | Carol Cole Company 1325 Sycamore Avenue, Suite A Vista, CA 92081 |
| Contact | Merle Kovacic |
| Correspondent | Merle Kovacic Carol Cole Company 1325 Sycamore Avenue, Suite A Vista, CA 92081 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-15 |
| Decision Date | 2016-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858398007008 | K161654 | 000 |
| 00854278006864 | K161654 | 000 |
| 00854278006857 | K161654 | 000 |