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enlighten Standard

by Cutera, Inc.

Ref ENLIGHTEN

enlighten Standard is a device classified as Class IIb in the EU and Class II in the US made by Cutera, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-00816722021601) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722021601), withdrawn as of 24 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816722021601 Basic UDI-DI 00816722021601UDI-DIDate12 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00816722021601 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722021601 registered 12 Oct 2026 Withdrawn
  • FDA GUDID UDI-DI 00816722021601 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722021601
  2. Registered EUDAMED B-00816722021601

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
enlighten
Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
ENLIGHTEN EUDAMED
enlighten Standard GUDID
Primary DI / UDI-DI
00816722021601
Basic UDI-DI
B-00816722021601
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ENLIGHTEN
GUDID
enlighten Standard
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: Dermatological frequency-doubled solid-state laser system

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Cutera, Inc.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)