510(k) · Cleared
ClearedNuface Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carol Cole Company · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Nov 7, 2011 as substantially equivalent to K072260 (Carol Cole Company, 2007) after a 348-day review. Its family tree reaches back 2 generations to 2001. 94 later devices descend from it.
- Decided
- Nov 7, 2011
- Review
- 348 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011935 (2001). 3 ancestors in all. 94 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 1 generation backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- This deviceK103472 Nuface PlusCarol Cole Company · 2011
- Descendant · cites it directly · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 2 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 3 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · cites it directly · 22 of its ownK181008 NuFACE TrinityCarol Cole Company Dba Nuface · 2018
- Descendant · 4 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · cites it directly58descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 2 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 3 generations on39descendants
- K181008NuFACE TrinityCarol Cole Company Dba Nuface · 2018 · cites it directly22descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −1 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| 0 (this device) | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| +1 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +2 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +3 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +1 | K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018 | — |
| +4 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 36 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K072260 | Nuface, Model NU-4003Summary page 1…r (21 CFR 882.5890) Product Code: NFO PREDICATE DEVICE The Carol Cole Company is claiming substantial equivalence with its own device, the NOFACE® device, cleared under K072260. This Abbreviated 510(k) submission is a new design based on the manufacturer's cleared device. Both devices are for transcutaneo… | 2007 |
What descends from it? (94)
See all 9410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171821 | 2 Face / Face Evolution | 2018 | 58 |
| K181008 | NuFACE Trinity | 2018 | 22 |
| K171588 | NuBODY Skin Toning Device | 2017 | 17 |
| K131251 | Trinity Ele | 2013 | 13 |
| K133823 | Nuface Mini Device | 2014 | 4 |
| K161484 | ZIIP Device | 2017 | 3 |
| K122711 | Facial Spa | 2013 | 2 |
| K163470 | Galvanic Spa, Model: SKB-1405 | 2017 | 1 |
| K163550 | Pobling MIITY 2 | 2017 | 0 |
| K162106 | Micro-current Wrinkle Reduction Facial service, model EP-400 | 2017 | 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 10 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171821 (Heat IN A Click, 2018) has gone furthest, with 58 descendants of its own.
- 7 other devices also cite its predicate K072260.
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. 2011, 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 NOFACE® Plus Facial Toning Device is intended for facial stimulation and
is indicated for over-the-counter cosmetic use (21 CFR 507 Subpart C):
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103472: Nuface Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103472
Report an extraction error
Are you the manufacturer?
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