510(k) · Cleared
ClearedNuFACE FIX Skin Toning Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carol Cole Company Dba Nuface · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Dec 18, 2018 as substantially equivalent to K131251 (Carol Cole Company, 2013) after a 103-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Dec 18, 2018
- Review
- 103 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011935 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 3 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 2 generations backK103472 Nuface PlusCarol Cole Company · 2011
- 1 generation backK131251 Trinity EleCarol Cole Company · 2013
- This deviceK182424 NuFACE FIX Skin Toning DeviceCarol Cole Company Dba Nuface · 2018
- Descendant · cites it directly · 0 of its ownK240564 NuFACE® FIX+Carol Cole Company Dba Nuface® · 2024
Most influential descendants
Showing 1 of 1 · See all- K240564NuFACE® FIX+Carol Cole Company Dba Nuface® · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −3 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −2 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| −1 | K131251 | Trinity Ele | Carol Cole Company | 2013 | — |
| 0 (this device) | K182424 | NuFACE FIX Skin Toning Device | Carol Cole Company Dba Nuface | 2018 | — |
| +1 | K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131251 | Trinity EleSummary page 4…NFO PREDICATE DEVICES The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use: 510(k) Number: K131251 Manufacturer: Carol Cole Company dba NuFACE Trade Name: Trinity ELE Product Code: NFO DEVICE DESCRIPTION… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240564 | NuFACE® FIX+ | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K240564 (Carol Cole Company Dba Nuface®, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131251.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182424: NuFACE FIX Skin Toning Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182424
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026