510(k) · Cleared
ClearedNuface, Model NU-4003
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 27, 2007 as substantially equivalent to K040871 (Facemaster of Beverly Hills, Inc., 2005) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 2001. 114 later devices descend from it.
- Decided
- Nov 27, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011935 (2001). 2 ancestors in all. 114 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- This deviceK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- Descendant · cites it directly · 94 of its ownK103472 Nuface PlusCarol Cole Company · 2011
- Descendant · 2 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 3 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 4 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 22 of its ownK181008 NuFACE TrinityCarol Cole Company Dba Nuface · 2018
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K103472Nuface PlusCarol Cole Company · 2011 · cites it directly94descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 2 generations on58descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 3 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 4 generations on39descendants
- K181008NuFACE TrinityCarol Cole Company Dba Nuface · 2018 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| 0 (this device) | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| +1 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| +2 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +3 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +4 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +2 | K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 40 | 0 |
| 2026 | 19 | 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? (2)
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 |
|---|---|---|---|
| * | K040871 | Facemaster Facial Toning SystemSummary page 1…evices to which the Carol Cole Company is claiming equivalence include the following transcutaneous electrical nerve stimulator devices for cosmetic use: 510(k) Number: K040871 Manufacturer: FaceMaster of Beverly Hills, Inc. Trade Name: FaceMaster Facial Toning System Product Code: NFO 510(k) Number: K01… | 2005 |
| * | K011935 | Rejuvenique Model #RJV10Summary page 1…s for cosmetic use: 510(k) Number: K040871 Manufacturer: FaceMaster of Beverly Hills, Inc. Trade Name: FaceMaster Facial Toning System Product Code: NFO 510(k) Number: K011935 Manufacturer: Salton, Inc. Trade Name: Rejuvenique Product Codes: NFO and GYB INDICATIONS FOR USE/INTENDED USE The NuFace® Facia… | 2001 |
What descends from it? (114)
See all 1148 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103472 | Nuface Plus | 2011 | 94 |
| K130065 | Beautiful Image Facial Sculpting Device | 2014 | 17 |
| K142794 | Everyway Facial MENS | 2015 | 12 |
| K190269 | PureLift | 2019 | 9 |
| K120511 | Ageless Wonder Facial Muscle Stimulation System | 2012 | 4 |
| K150826 | Nutra Face Lift Model PE8050 | 2016 | 0 |
| K150077 | SonicLift | 2015 | 0 |
| K102494 | The Buzz Facial Toning System | 2011 | 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?
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. 2007, 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® Facial Toning Device is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072260: Nuface, Model NU-4003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072260
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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