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Medical Diode Laser

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref No510(k) K240747Ref N/AModel S1-K12

by Wuhan Pioon Technology Co., Ltd

Identity

Device Name
Medical Diode Laser EUDAMED
Model / Reference
No EUDAMED
S1-K12 EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
D-CN-MF-000018399TG EUDAMED
06974624060075 EUDAMED
Basic UDI-DI
B-CN-MF-000018399TG EUDAMED
B-06974624060075 EUDAMED
510(k) Number
K240747 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
EMDN Code
Z12011016 DIODE SURGICAL LASER EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Market of Registration
Germany EUDAMED
Türkiye EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Medical Diode Laser by Wuhan Pioon Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Wuhan Pioon Technology Co., Ltd
EUDAMED SRN
CN-MF-000018399
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (3)

  • EUDAMED 2081f3d1-8bc9-430d-959f-fd8a5b924328 61 fields · synced Jul 25, 2026
  • FDA 510(k) K240747 24 fields · synced May 18, 2026
  • EUDAMED 0982ee4e-d512-4449-b3bf-0c432d1739c8 61 fields · synced Jul 25, 2026