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enlighten SR

by Cutera, Inc.

Ref ENLIGHTENSR

enlighten SR (ENLIGHTENSR) is a medical device (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument; EMDN category multi–platform laser) made by Cutera, Inc., registered in EUDAMED on 2 Nov 2024 (Basic UDI-DI B-00816722021625) and listed in FDA GUDID since 2 Mar 2018 (UDI-DI 00816722021625), active as of 25 Oct 2026.

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

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816722021625 Basic UDI-DI 00816722021625UDI-DIDate2 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722021625 UDI-DI Date2 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722021625 registered 2 Nov 2024 Active
  • FDA GUDID UDI-DI 00816722021625 listed 2 Mar 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722021625
  2. Registered EUDAMED B-00816722021625

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
enlighten SR EUDAMED
enlighten GUDID
Generic name
Dermatological frequency-doubled solid-state laser system
Device name
enlighten Family
Model / reference
ENLIGHTENSR EUDAMED
enlighten SR GUDID
Primary DI / UDI-DI
00816722021625
Basic UDI-DI
B-00816722021625, 00816722021600DC
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)
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ENLIGHTENSR
GUDID
enlighten SR
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
US-MF-000010456
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Cutera, Inc.

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    Class II

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See all devices from Cutera, Inc. →

Properties

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