# K131758: Surgen U

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Dec 18, 2013 after 184 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). 225 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102461: Fractora, Invasix, Ltd. (2011) Summary page 1.

## Most influential descendants
- K171359: Pollogen Legend+ System (2017), 4 descendants of its own
- K173503: Pollogen Legend System (2018), 3 descendants of its own
- K233473: Deka Lotus (2024), 1 descendant of its own
- K250281: Deka Lotus (2025), 0 descendants of its own
- K220124: YandR System, VoluDerm Handpiece, VoluDerm Tips (2022), 0 descendants of its own

## Indications for use
Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K131758
Methodology: https://510kreport.com/methodology