The following data is part of a premarket notification filed by Carol Cole Company Dba Nuface with the FDA for Trinity Plus Wrinkle Reducer.
| Device ID | K212947 |
| 510k Number | K212947 |
| Device Name: | Trinity Plus Wrinkle Reducer |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Carol Cole Company Dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081 |
| Contact | David Reece |
| Correspondent | Bob Duffy Bob Duffy Associates, Inc. 16405 Summer Sage Rd. Poway, CA 92064 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019720303 | K212947 | 000 |