# K232903: Legend X Platform

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Oct 17, 2023 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30, Genzyme Diagnostics P.E.I., Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips, Macromedics BV (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K240999: Legend X Applicator VO (2024), 1 descendant of its own
- K253803: MILAN System (2026), 0 descendants of its own
- K252576: Legend X Platform (2025), 0 descendants of its own
- K243217: Legend X Desktop System (2024), 0 descendants of its own

## 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 RF Energy and for muscle conditioning to stimulate healthy muscles (Applicators 1-3). Legend X Platform is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend X Platform is intended to be operated by a trained professional who is present to monitor treatment.

Source page: https://510kreport.com/device/K232903
Methodology: https://510kreport.com/methodology