# K161654: NuFACE Gel Primer

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company
- Decided: Dec 30, 2016 after 198 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961050 (1997). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032239: Thera-Cream, Model TCT004, Prizm Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- K243749: Jmoon Conductive Gel (2025), 0 descendants of its own
- K220735: Avologi Gel Primer (Model: Av25) (2023), 0 descendants of its own

## Indications for use
The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.

Source page: https://510kreport.com/device/K161654
Methodology: https://510kreport.com/methodology