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Luxora System AG613237A

by Inmode MD, Ltd.

Luxora System AG613237A (AG613238A) is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K240780 on 24 Jul 2024 (2 earlier submissions) and listed in FDA GUDID since 11 Aug 2025 (UDI-DI 07290019863267), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290019863267 UDI-DI Date11 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240780 Date24 Jul 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240780 decided 24 Jul 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 07290019863267 listed 11 Aug 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K210492
  2. Cleared FDA 510(k) K231790
  3. Cleared FDA 510(k) K240780
  4. Listed FDA GUDID 07290019863267

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Luxora System
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
AG613237A, AG613238A
Primary DI / UDI-DI
07290019863267
510(k) Number
FDA product code
GEI
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K210492)

and 6 more cleared under K210492

Cleared under the same submission (K231790)

and 2 more cleared under K231790

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)