# K220735: Avologi Gel Primer (Model: Av25)

- Pathway: 510(k) (Traditional)
- Applicant: Premier North America, Inc.
- Decided: Sep 15, 2023 after 550 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: 7 generations back to K961050 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161654: NuFACE Gel Primer, Carol Cole Company (2016) Summary page 4.

## Indications for use
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity

Source page: https://510kreport.com/device/K220735
Methodology: https://510kreport.com/methodology