# K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa)

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: May 14, 2014 after 103 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 90 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K111026: Apollo, Pollogen, Ltd. (2011) Summary page 1.

## Most influential descendants
- K182774: STOP U (Packed Black USA), STOP U (Packed White USA) (2019), 5 descendants of its own
- 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

## Indications for use
Pollagen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Source page: https://510kreport.com/device/K140255
Methodology: https://510kreport.com/methodology