# K252576: Legend X Platform

- Pathway: 510(k) (Special)
- Applicant: Pollogen, Ltd.
- Decided: Sep 12, 2025 after 29 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: 1 generation back to K232903 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232903: Legend X Platform, Pollogen, Ltd. (2023) Summary page 5.

## Indications for use
The Legend X Platform and its accessories are 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 radiofrequency (RF) Energy and for transcutaneous electrical stimulation of periorbital, facial, and body muscles with DMSt (Dynamic Muscle Stimulation technology) for aesthetic purposes, including improvement of appearance, and for body muscle conditioning to stimulate healthy muscles. (Applicators 1-3).

Source page: https://510kreport.com/device/K252576
Methodology: https://510kreport.com/methodology