510(k) · Cleared
ClearedNuface Mini Device
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 Apr 17, 2014 as substantially equivalent to K103472 (Carol Cole Company, 2011) after a 121-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011935 (2001). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 2 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 1 generation backK103472 Nuface PlusCarol Cole Company · 2011
- This deviceK133823 Nuface Mini DeviceCarol Cole Company · 2014
- Descendant · cites it directly · 1 of its ownK152199 RejuvatoneMDTrophy Skin, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK260179 VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK182025 ClearUP Sinus Pain ReliefTivic Health Systems, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK171647 BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K152199RejuvatoneMDTrophy Skin, Inc. · 2016 · cites it directly1descendant
- K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · 2026 · cites it directly0descendants
- K182025ClearUP Sinus Pain ReliefTivic Health Systems, Inc. · 2019 · 2 generations on0descendants
- K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −2 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −1 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| 0 (this device) | K133823 | Nuface Mini Device | Carol Cole Company | 2014 | — |
| +1 | K152199 | RejuvatoneMD | Trophy Skin, Inc. | 2016 | — |
| +1 | K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026 | — |
| +2 | K182025 | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | 2019 | — |
| +1 | K171647 | BeneLife Premium Facial Treatment Pack, Model: QZ0701A | Infinitus (China) Company, Ltd. | 2017 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K103472 | Nuface PlusSummary page 1…O PREDICATE DEVICE The Carol Cole Company is claiming substantial equivalence with its own device, the NuFACE® Trinity device, cleared as the NuFACE®D Plus under 510(k) K103472. This Abbreviated 51 0(k) submission is a new design based on the manufacturer's cleared device. The electrical output of the NuF… | 2011 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152199 (Trophy Skin, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K103472.
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. 2014, 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®E Mini Facial Toning device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21I CFR 807 Subpart C).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133823: Nuface Mini Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133823
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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