Carol Cole Company Dba Nuface: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Carol Cole Company Dba Nuface” (first 2017, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 177 days. Since 2017 the median was 177 days, against 98 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 61 |
| 2018 | 2 | 140 |
| 2019 | 1 | 113 |
| 2020 | 0 | — |
| 2021 | 2 | 218 |
| 2022 | 1 | 199 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carol Cole Company Dba Nuface took a median 177 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 6 | 6 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
Review panels
Most recent Carol Cole Company Dba Nuface 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212947 | Trinity Plus Wrinkle Reducer | OHS | 2022-04-02 | 199 |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | NFO | 2021-02-24 | 230 |
| K201782 | NuFace Trinity Plus Device | NFO | 2021-01-22 | 206 |
| K191672 | NuFACE Mini Device | NFO | 2019-10-15 | 113 |
| K182424 | NuFACE FIX Skin Toning Device | NFO | 2018-12-18 | 103 |
| K181008 | NuFACE Trinity | NFO | 2018-10-11 | 177 |
| K171588 | NuBODY Skin Toning Device | NFO | 2017-07-31 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Carol Cole Company Dba Nuface.
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 (6 510(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 Dba Nuface?
FDA lists 7 510(k) clearances under the applicant name “Carol Cole Company Dba Nuface” (first 2017, latest 2022), across 2 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 Dba Nuface?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carol Cole Company Dba Nuface is 177 days. Since 2017: 177 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carol Cole Company Dba Nuface?
The most frequent FDA product codes under this applicant name are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 6); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Next steps
- See all 7 Carol Cole Company Dba Nuface clearances with predicates and recalls
- Run predicate analysis for product code NFO, Carol Cole Company Dba Nuface'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.