# K240999: Legend X Applicator VO

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: May 8, 2024 after 27 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: 21 generations back to K943450 (1995). 261 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 263 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.
- K200947: InMode System with the Morhpeus8 Applicators, InMode, Ltd. (2020) Summary page 6.

## Most influential descendants
- K253803: MILAN System (2026), 0 descendants of its own

## Indications for use
The Legend X Applicator VO and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (tips gen12, gen100, gen 36, gen36L, H7x7). The Legend X Applicator VO with genXL tip is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Applicator VO with genXL tip is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K240999
Methodology: https://510kreport.com/methodology