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FDA 510(k)

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

K-Number: K260129 · 2026-04-15

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2026-04-15
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K260129.

When was Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) approved by the FDA?

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

What company makes Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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