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Lilium one (USM330)

by Lilium Otsuka Co., Ltd.

510(k) K260605

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 1 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 1 Nov 2026. What this means

Regulatory status

as of registry sync 1 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK260605 Date16 Oct 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 1 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Lilium Otsuka Co., Ltd.

  • Lilium a-200E

    Class II