# K253803: MILAN System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis Be, Ltd.
- Decided: Jun 2, 2026 after 186 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: 22 generations back to K943450 (1995). 262 ancestors in all.
No later device cites it as a predicate yet.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240999: Legend X Applicator VO, Pollogen, Ltd. (2024) Summary page 5.

## Indications for use
The MILAN System is indicated for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, the use of the Milan System with its disposable tips is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K253803
Methodology: https://510kreport.com/methodology