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Smaxel

by Ids Ltd.

Ref IDS-UM-0511Model SMAXEL

Smaxel (IDS-UM-0511) is a dermatological carbon dioxide laser system (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Ids Ltd., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-08809578390009), cleared under FDA 510(k) K180036 on 2 Feb 2018 and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 08809578390009), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K180036; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180036

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809578390009 Basic UDI-DI 08809578390009UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809578390009 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK180036 Date2 Feb 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809578390009 registered 26 Oct 2026 Active
  • FDA 510(k) K180036 decided 2 Feb 2018 Active
  • FDA GUDID UDI-DI 08809578390009 listed 31 Dec 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0804-2025 FDA Class II initiated 16 Oct 2024 on shared 510(k) K180036

    The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K180036
  2. Listed FDA GUDID 08809578390009
  3. Recall initiated FDA recalls Z-0804-2025
  4. Registered EUDAMED B-08809578390009

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Smaxel EUDAMED
Fractional CO2 Laser GUDID
Generic name
Dermatological carbon dioxide laser system
Model / reference
SMAXEL, IDS-UM-0511
Primary DI / UDI-DI
08809578390009
Basic UDI-DI
B-08809578390009
510(k) Number
FDA product code
GEX
EMDN code
Z12011005 Carbon dioxide surgical laser
GMDN term
Dermatological carbon dioxide laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
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.

Manufacturer details

EUDAMED SRN
KR-MF-000018259
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under CARBON DIOXIDE SURGICAL LASER.

Other devices from Ids Ltd.

See all devices from Ids Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)