Data / Medical devices / United States / Carol Cole Company dba NuFACE
Carol Cole Company dba NuFACE: FDA-registered device maker in Vista, CA, United States, 15 510(k) clearances
Carol Cole Company dba NuFACE is registered with the FDA (registration 3006459199) in Vista, CA, United States. It lists 3 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006459199
- Address
- 1325 Sycamore Ave Ste B, Vista, CA, United States, 92081
- Owner or operator
- Carol Cole Company (9106439)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 23, 2012
- Registered through
- 2026
- Brand names listed
- FIX MicroWand (FIX+), Labeling Information Pilot Program Participants Only, Micro Dermal Tone MDT Professional Home Care Device, NuFACE Classic, NuFACE FIX Device, NuFACE Gel Primer, NuFACE Mini, NuFACE Mini Facial and Neck Skin Toning Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2024 | K240564 | NuFACE® FIX+ | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface® | accessdata.fda.gov |
| April 2, 2022 | K212947 | Trinity Plus Wrinkle Reducer | OHS | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| February 24, 2021 | K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| February 19, 2021 | K201680 | NuFACE Mini Plus | NFO | Substantially Equivalent | Carole Cole Company | accessdata.fda.gov |
| January 22, 2021 | K201782 | NuFace Trinity Plus Device | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| October 15, 2019 | K191672 | NuFACE Mini Device | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| December 18, 2018 | K182424 | NuFACE FIX Skin Toning Device | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| October 11, 2018 | K181008 | NuFACE Trinity | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| July 31, 2017 | K171588 | NuBODY Skin Toning Device | NFO | Substantially Equivalent | Carol Cole Company Dba Nuface | accessdata.fda.gov |
| December 30, 2016 | K161654 | NuFACE Gel Primer | GYB | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
| April 17, 2014 | K133823 | NUFACE MINI DEVICE | NFO | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
| October 1, 2013 | K131251 | TRINITY ELE | NFO | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
| November 6, 2012 | K120560 | TRINITY WRINKLE REMOVER | OHS | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
| November 7, 2011 | K103472 | NUFACE PLUS | NFO | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
| November 27, 2007 | K072260 | NUFACE, MODEL NU-4003 | NFO | Substantially Equivalent | Carol Cole Company | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Media, Electroconductive
Updated June 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.