# K182774: STOP U (Packed Black USA), STOP U (Packed White USA)

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Jun 19, 2019 after 261 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: 18 generations back to K943450 (1995). 92 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa), Pollogen, Ltd. (2014) Summary page 4.
- DEN150005: Newa Skin Therapy System, Endymed Medical, Ltd. (2015) Summary page 4.

## Most influential descendants
- K203665: STOP U Model UXV Device (2021), 4 descendants of its own
- K220322: Pollogen STOP U Model UXV Device (2023), 3 descendants of its own
- K250341: Sensilift Pro (ST300XXYYZZZ) (2026), 0 descendants of its own
- K233766: Geneo X Elite (2024), 0 descendants of its own
- K232424: CurrentBody Skin RF (2024), 0 descendants of its own

## Indications for use
The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.

Source page: https://510kreport.com/device/K182774
Methodology: https://510kreport.com/methodology