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FDA 510(k)

Demi Pro

K-Number: K253461 · 2025-10-14

ApplicantMeta Systems Co., Ltd.
Decision Date2025-10-14
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Demi Pro is a medical device manufactured by Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-10-14 under approval number K253461. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Demi Pro?

Demi Pro is a medical device that received FDA 510(k) clearance on 2025-10-14. It is manufactured by Meta Systems Co., Ltd.. The 510(k) number is K253461.

When was Demi Pro approved by the FDA?

Demi Pro received FDA 510(k) clearance on 2025-10-14, under approval number K253461.

What company makes Demi Pro?

Demi Pro is manufactured by Meta Systems Co., Ltd..

What is the FDA product code for Demi Pro?

The FDA product code for Demi Pro is EBZ.

Other Devices by Meta Systems Co., Ltd.

K153285EMS-200 K210789EQ-PEX K210475EQ-M

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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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