510(k) · Cleared
ClearedVITA Multi-Function Head Brush (TB-2343F, TB-2442F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Jun 3, 2026 as substantially equivalent to K221443 (Xtreem Pulse, LLC, 2022) and 2 other predicates after a 133-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 3, 2026
- Review
- 133 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K011935 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 5 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 4 generations backK103472 Nuface PlusCarol Cole Company · 2011
- 3 generations backK171588 NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface · 2017
- 2 generations backK191951 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
- 1 generation backK233010 Beagank 4T PlusBelega, Inc. · 2023
- This deviceK260179 VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −5 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −4 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| −3 | K171588 | NuBODY Skin Toning Device | Carol Cole Company Dba Nuface | 2017 | — |
| −2 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | Avazzia, Inc. | 2021 | — |
| −1 | K233010 | Beagank 4T Plus | Belega, Inc. | 2023 | — |
| 0 (this device) | K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K221443 | PureLift Pro PlusSummary page 5…cate Device Manufacturer Predicate Device 510(k) Number Cleared Date XTREEM PULSE LLC PureLift Pro Plus K221443 October 21, 2022 BELEGA Co., Ltd. Beagank 4T Plus K233010 November 21, 2023… | 2022 |
| * | K233010 | Beagank 4T PlusSummary page 5…red Date XTREEM PULSE LLC PureLift Pro Plus K221443 October 21, 2022 BELEGA Co., Ltd. Beagank 4T Plus K233010 November 21, 2023 Carol Cole Company NuFACE Mini Device K133823 Apr 17, 2014 IV.… | 2023 |
| * | K133823 | Nuface Mini DeviceSummary page 5…1, 2022 BELEGA Co., Ltd. Beagank 4T Plus K233010 November 21, 2023 Carol Cole Company NuFACE Mini Device K133823 Apr 17, 2014 IV. Device Description The VITA Multi-Function Head Brush is a hand-held device. It consists of a host… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- None of the 11 ancestors has a recall.
- 5 other devices also cite its predicate K221443.
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. 2026, 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?
VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.
Micro-current function: The micro current stimulation mode 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/K260179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260179: VITA Multi-Function Head Brush (TB-2343F, TB-2442F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260179
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026