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MultiPulse TFL

by Asclepion Laser Technologies GmbH

Ref J19-8000-000

MultiPulse TFL (J19-8000-000) is a general/multiple surgical solid-state laser system (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, registered in EUDAMED on 1 Apr 2026 (Basic UDI-DI 4058784J198XQP), cleared under FDA 510(k) K253100 on 23 Oct 2025 and listed in FDA GUDID since 27 Nov 2025 (UDI-DI 04058784002655), 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) K253100↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4058784J198XQP Basic UDI-DI 04058784002655UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04058784002655 UDI-DI Date27 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK253100 Date23 Oct 2025IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4058784J198XQP registered 1 Apr 2026 Active
  • FDA 510(k) K253100 decided 23 Oct 2025 Active
  • FDA GUDID UDI-DI 04058784002655 listed 27 Nov 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K253100
  2. Listed FDA GUDID 04058784002655
  3. Registered EUDAMED 4058784J198XQP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
General/multiple surgical solid-state laser system
Model / Ref / Catalog
J19-8000-000
Primary DI / UDI-DI
04058784002655
Basic UDI-DI
4058784J198XQP
Direct marketing DI
04058784002655
510(k) Number
FDA product code
GEX
EMDN code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN term
General/multiple surgical 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
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.

Manufacturer details

EUDAMED SRN
DE-MF-000005158

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 (22, all answered No)