510(k) · Cleared
ClearedNuFACE Gel Primer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carol Cole Company · GYB Media, Electroconductive
Cleared on Dec 30, 2016 as substantially equivalent to K032239 (Prizm Medical, Inc., 2004) after a 198-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 30, 2016
- Review
- 198 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961050 (1997). 12 ancestors in all, the oldest K782055 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 5 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 4 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 3 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 2 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 1 generation backK032239 Thera-Cream, Model TCT004Prizm Medical, Inc. · 2004
- This deviceK161654 NuFACE Gel PrimerCarol Cole Company · 2016
- Descendant · cites it directly · 0 of its ownK243749 Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220735 Avologi Gel Primer (Model: Av25)Premier North America, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −5 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −4 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| −3 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| −2 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| −1 | K032239 | Thera-Cream, Model TCT004 | Prizm Medical, Inc. | 2004 | — |
| 0 (this device) | K161654 | NuFACE Gel Primer | Carol Cole Company | 2016 | — |
| +1 | K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
| +1 | K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 GYB? 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 GYB device
- #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 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 |
|---|---|---|---|
| * | K032239 | Thera-Cream, Model TCT004Summary page 4…GYB Predicate Device The legally marketed device to which NuFACE® claims substantial equivalence is the Prizm Medical, Inc. Thera-CreamTM. 510(k) Number: K032239 Manufacturer: Prizm Medical, Inc. Trade Name: Thera-Cream Product Code: GYB Device Description The NuFAC… | 2004 |
What descends from it? (2)
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 19 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K243749 (Shenzhen Ulike Smart Electronics Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GYB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYB
101in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GYB
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYB
2in 2025
MAUDE reports naming product code GYB, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 3 | 198 | 0 | 2 |
| 2021 | 2 | — | 1 (1) | 4 |
| 2022 | 3 | 101 | 0 | 4 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161654: NuFACE Gel Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161654
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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