510(k) · Cleared
ClearedNuFace Trinity Plus 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 Jan 22, 2021 as substantially equivalent to K181008 (Carol Cole Company Dba Nuface, 2018) after a 206-day review. Its family tree reaches back 4 generations to 2001. 5 later devices descend from it.
- Decided
- Jan 22, 2021
- Review
- 206 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. 5 later devices descend from it, 2 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 backK181008 NuFACE TrinityCarol Cole Company Dba Nuface · 2018
- This deviceK201782 NuFace Trinity Plus DeviceCarol Cole Company Dba Nuface · 2021
- Descendant · cites it directly · 2 of its ownK212342 ZIIP+ DeviceZiip, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK243587 PureLift GLOWXtreem Pulse, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232863 Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK213078 Myolift QTJohari Digital Healthcare Limited · 2023
Most influential descendants
Showing 5 of 5 · See all- K212342ZIIP+ DeviceZiip, Inc. · 2021 · cites it directly2descendants
- K243587PureLift GLOWXtreem Pulse, LLC · 2025 · cites it directly1descendant
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2023 · 2 generations on0descendants
- K213078Myolift QTJohari Digital Healthcare Limited · 2023 · 2 generations on0descendants
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 | K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018 | — |
| 0 (this device) | K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | 2021 | — |
| +1 | K212342 | ZIIP+ Device | Ziip, Inc. | 2021 | — |
| +1 | K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025 | — |
| +2 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +2 | K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023 | — |
| +2 | K213078 | Myolift QT | Johari Digital Healthcare Limited | 2023 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K181008 | NuFACE TrinitySummary page 4…ion on the legally marketed predicate device to which the Carol Cole Company dba NūFACE is claiming substantial equivalence to: 510(k) Number: K181008 Manufacturer: Carol Cole Company dba NūFACE Trade Name: NūFACE® Trinity Re… | 2018 |
| † | K161654 | NuFACE Gel Primer | 2016 |
What descends from it? (5)
2 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 20 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K212342 (Ziip, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K181008.
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. 2021, 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® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the counter cosmetic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201782: NuFace Trinity Plus Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201782
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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