The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Trinity Ele Plus And Trinity Ele Plus Pro.
| Device ID | K201906 |
| 510k Number | K201906 |
| Device Name: | Trinity ELE Plus And Trinity ELE Plus Pro |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company Dba NuFACE 1325 Sycamore Avenue, Suite A Vista, CA 92081 |
| Contact | Danielle Barker Fernandes |
| Correspondent | Bob Duffy Bob Duffy Associates, Inc. 16405 Summer Sage Rd. Poway, CA 92064 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2020-07-09 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019720280 | K201906 | 000 |