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ADVATx 1.0

by Advalight Aps

Ref ADVATxModel 1.4

ADVATx 1.0 (684) is a device classified as Class IIb in the EU and Class II in the US made by Advalight Aps, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 57000020522A00B4), cleared under FDA 510(k) K132976 on 17 Apr 2014 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05700002052209), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132976

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57000020522A00B4 Basic UDI-DI 05700002052209UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700002052209 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132976 Date17 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 57000020522A00B4 registered 21 May 2026 Active
  • FDA 510(k) K132976 decided 17 Apr 2014 Active
  • FDA GUDID UDI-DI 05700002052209 listed 18 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132976
  2. Listed FDA GUDID 05700002052209
  3. Registered EUDAMED 57000020522A00B4

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  • Withdrawn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
ADVATx
Generic name
Dermatological frequency-doubled solid-state laser system
Model / Ref / Catalog
1.4 EUDAMED
ADVATx EUDAMED
1.0 GUDID
684 GUDID
Primary DI / UDI-DI
05700002052209
Basic UDI-DI
57000020522A00B4
Direct marketing DI
05700002052209
510(k) Number
FDA product code
GEX
EMDN code
Z12040202 Phototherapy equipment
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
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1.4
ADVATx
GUDID
1.0
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 PHOTOTHERAPY EQUIPMENT.

Other devices from Advalight Aps

  • AdvaTx

    Class II

  • Advatx

    Class II

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)