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xeo

by Cutera, Inc.

Part of a family of 11 devices: see the family page

Ref XEO

xeo is a device classified as Class IIb in the EU and Class II in the US made by Cutera, Inc., registered in EUDAMED on 2 Nov 2024 (Basic UDI-DI B-00816722021106) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722021106), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00816722021106 Basic UDI-DI 00816722021106UDI-DIDate2 Nov 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00816722021106 Basic UDI-DI 00816722021106UDI-DIDate2 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722021106 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722021106 registered 2 Nov 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00816722021106 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722021106
  2. Registered EUDAMED B-00816722021106

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Multi-modality skin surface treatment system
Device name
xeo+ Family
Model / reference
xeo
Primary DI / UDI-DI
00816722021106
Basic UDI-DI
B-00816722021106, 00816722021800DN
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Multi-modality skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multi-modality skin surface treatment system

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Cutera, Inc.

  • truSculpt iD

    Class II

  • Titan V

    Class II

  • CoolView

    Class II

  • AviClear

    Class II

See all devices from Cutera, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)