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enlighten Micro Lens Array (MLA)

by Cutera, Inc.

Ref 7001630

enlighten Micro Lens Array (MLA) (7001630) is a medical device (EU MDR 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 5 Jan 2026 (Basic UDI-DI 00816722021600DC), cleared under FDA 510(k) K182997 on 12 Dec 2018 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00816722023605), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182997

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00816722021600DC Basic UDI-DI 00816722023605UDI-DIDate5 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722023605 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182997 Date12 Dec 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00816722021600DC registered 5 Jan 2026 Active
  • FDA 510(k) K182997 decided 12 Dec 2018 Active
  • FDA GUDID UDI-DI 00816722023605 listed 14 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182997
  2. Listed FDA GUDID 00816722023605
  3. Registered EUDAMED 00816722021600DC

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
enlighten Micro Lens Array (MLA) EUDAMED
enlighten GUDID
Generic name
Dermatological frequency-doubled solid-state laser system
Device name
enlighten Family
Model / reference
7001630 EUDAMED
Micro Lens Array GUDID
Primary DI / UDI-DI
00816722023605
Basic UDI-DI
00816722021600DC
510(k) Number
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
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
7001630
GUDID
Micro Lens Array
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.

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Properties

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