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FDA 510(k)

TRUDERMAL Pro (ZLD-390)

K-Number: K251012 · 2025-08-14

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-08-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRUDERMAL Pro (ZLD-390) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under approval number K251012. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUDERMAL Pro (ZLD-390)?

TRUDERMAL Pro (ZLD-390) is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251012.

When was TRUDERMAL Pro (ZLD-390) approved by the FDA?

TRUDERMAL Pro (ZLD-390) received FDA 510(k) clearance on 2025-08-14, under approval number K251012.

What company makes TRUDERMAL Pro (ZLD-390)?

TRUDERMAL Pro (ZLD-390) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for TRUDERMAL Pro (ZLD-390)?

The FDA product code for TRUDERMAL Pro (ZLD-390) is OHS.

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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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