NuFACE Trinity
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Carol Cole Company Dba NuFACE
The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Nuface Trinity.
Pre-market Notification Details
| Device ID | K181008 |
| 510k Number | K181008 |
| Device Name: | NuFACE Trinity |
| 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 | 2018-04-17 |
| Decision Date | 2018-10-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810075940176 | K181008 | 000 |
| 00810075940145 | K181008 | 000 |
Trademark Results [NuFACE Trinity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUFACE TRINITY 85945154 4627113 Live/Registered |
Carol Cole Company 2013-05-29 |
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