FDA 510(k)

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

N.º K: K260129 · 2026-04-15

SolicitanteShenzhen Kaiyan Medical Equipment Co., Ltd.

Fecha de decisión2026-04-15

Código de productoOLI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260129. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K260129.

When did Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) receive FDA 510(k) clearance?

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260129.

Who is the listed applicant for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

The FDA product code for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is OLI.

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Fuente oficial

Ver en la base de datos de la FDA →

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