# K233766: Geneo X Elite

- Pathway: 510(k) (Special)
- Applicant: Pollogen, Ltd.
- Decided: May 7, 2024 after 165 days
- Product code: PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220322: Pollogen STOP U Model UXV Device, Pollogen, Ltd. (2023) Summary page 6.

## Indications for use
The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV. The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

Source page: https://510kreport.com/device/K233766
Methodology: https://510kreport.com/methodology