Carol Cole Company dba NuFACE
Vista, CA, US
Carol Cole Company dba NuFACE appears in FDA device records in Vista, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Carol Cole Company dba NuFACE between 2017 and 2024. The busiest year on record is 2018, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240564 | NuFACE® FIX+ | NFO | Substantially Equivalent | |
| K212947 | Trinity Plus Wrinkle Reducer | OHS | Substantially Equivalent | |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | NFO | Substantially Equivalent | |
| K201782 | NuFace Trinity Plus Device | NFO | Substantially Equivalent | |
| K191672 | NuFACE Mini Device | NFO | Substantially Equivalent | |
| K182424 | NuFACE FIX Skin Toning Device | NFO | Substantially Equivalent | |
| K181008 | NuFACE Trinity | NFO | Substantially Equivalent | |
| K171588 | NuBODY Skin Toning Device | NFO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006459199 | 3006459199 | Carol Cole Company dba NuFACE | 1325 Sycamore Ave Ste B, Vista, CA 92081 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain