510(k) clearance

Lilium one (USM330)

FDA 510(k) source

510(k) number

K260605

Applicant

Lilium Otsuka Co., Ltd.

Decision date

Oct 16, 2026

Date received

Feb 24, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYO

Device type

System, Imaging, Pulsed Echo, Ultrasonic

Device class

Class II

Regulation

21 CFR 892.1560

Advisory committee

Radiology

Statement or summary

Summary

Third party

Y

Location

Kanagawa, JP