# K171359: Pollogen Legend+ System

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Sep 13, 2017 after 127 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: 18 generations back to K943450 (1995). 257 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 262 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 4.
- K131758: Surgen U, Pollogen, Ltd. (2013) Summary page 4.

## Most influential descendants
- 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
The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

Source page: https://510kreport.com/device/K171359
Methodology: https://510kreport.com/methodology