Carol Cole Company: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Carol Cole Company” (first 2007, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 176 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 256 |
| 2013 | 1 | 153 |
| 2014 | 1 | 121 |
| 2015 | 0 | — |
| 2016 | 1 | 198 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 4 | 4 |
| GYB | Media, Electroconductive | 1 | 1 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
Review panels
Most recent Carol Cole Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161654 | NuFACE Gel Primer | GYB | 2016-12-30 | 198 |
| K133823 | NUFACE MINI DEVICE | NFO | 2014-04-17 | 121 |
| K131251 | TRINITY ELE | NFO | 2013-10-01 | 153 |
| K120560 | TRINITY WRINKLE REMOVER | OHS | 2012-11-06 | 256 |
| K103472 | NUFACE PLUS | NFO | 2011-11-07 | 348 |
| K072260 | NUFACE, MODEL NU-4003 | NFO | 2007-11-27 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Carol Cole Company.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carol Cole Company Dba Nuface (7 510(k)s)
- Carol Block, Ltd. (1 510(k)s)
- Carol Cole Company Dba Nuface® (1 510(k)s)
- Carol Wright Sales (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carol Cole Company?
FDA lists 6 510(k) clearances under the applicant name “Carol Cole Company” (first 2007, latest 2016), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carol Cole Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carol Cole Company is 176 days.
Which FDA product codes appear under Carol Cole Company?
The most frequent FDA product codes under this applicant name are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 4); GYB (Media, Electroconductive, 1); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Next steps
- See all 6 Carol Cole Company clearances with predicates and recalls
- Run predicate analysis for product code NFO, Carol Cole Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.