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Medical Diode Laser

by Wuhan Pioon Technology Co., Ltd

Ref No510(k) K240747Model S1-K12

Medical Diode Laser (No) is a medical device (EU MDD Class IIb; FDA Class II; FDA product code GEX; EMDN category diode surgical laser) made by Wuhan Pioon Technology Co., Ltd., registered in EUDAMED on 14 Aug 2024 (Basic UDI-DI B-CN-MF-000018399TG) and cleared under FDA 510(k) K240747 on 17 Jun 2024, active as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240747↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CN-MF-000018399TG Basic UDI-DI Date14 Aug 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240747 Date17 Jun 2024ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-CN-MF-000018399TG registered 14 Aug 2024 Active
  • FDA 510(k) K240747 decided 17 Jun 2024 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K240747
  2. Registered EUDAMED B-CN-MF-000018399TG

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  • Withdrawn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)

Device name
Medical Diode Laser
Model / reference
No, S1-K12
Primary DI / UDI-DI
D-CN-MF-000018399TG, 06974624060075
Basic UDI-DI
B-CN-MF-000018399TG, B-06974624060075
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
Device class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Türkiye
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIb
510(k)
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
CN-MF-000018399
Authorised representative
Wellkang Ltd XI-AR-000001836

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

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Properties

Other properties (12, all answered No)