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QuadroStar PRO 1491

by Asclepion Laser Technologies GmbH

Ref 1491

QuadroStar PRO 1491 is a device classified as Class IIb in the EU and Class II in the US made by Asclepion Laser Technologies GmbH, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI B-04058784000033), cleared under FDA 510(k) K133297 on 10 Jun 2014 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 04058784000033), 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

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133297

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-04058784000033 Basic UDI-DI 04058784000033UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04058784000033 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133297 Date10 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04058784000033 registered 10 Aug 2026 Active
  • FDA 510(k) K133297 decided 10 Jun 2014 Active
  • FDA GUDID UDI-DI 04058784000033 listed 17 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133297
  2. Listed FDA GUDID 04058784000033
  3. Registered EUDAMED B-04058784000033

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  • Withdrawn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
QuadroStarPRO EUDAMED
QuadroStar PRO GUDID
Generic name
General/multiple surgical diode laser system
Model / reference
1491
Primary DI / UDI-DI
04058784000033
Basic UDI-DI
B-04058784000033
510(k) Number
FDA product code
GEX
EMDN code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN term
General/multiple surgical diode laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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.

Related devices

Category: General/multiple surgical diode laser system

Cleared under the same submission (K133297)

Similar devices in this category

Other devices filed under DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER.

Other devices from Asclepion Laser Technologies GmbH

See all devices from Asclepion Laser Technologies GmbH →

Properties

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