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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 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.

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. 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.

Other records listing Shenzhen Kaiyan Medical Equipment Co., Ltd. as applicant

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Related Devices (Code: OLI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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