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Dermatological Carbon Dioxide Laser System

by Zhuolu Jontelaser Manufacturing Technology Co.，Ltd.

Ref /Model L300

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202250↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06975568904012 Basic UDI-DI 06975568904012UDI-DIDate16 Apr 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK202250 Date25 Nov 2020IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
L300, /
Primary DI / UDI-DI
06975568904012
Basic UDI-DI
B-06975568904012
EMDN Code
Z120615 Therapeutic lasers
Device Class
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000017954
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zhuolu Jontelaser Manufacturing Technology Co.，Ltd.

Properties

  • Reusable

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No