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 |