FDA 510(k)

UNITY DX (UDX)

K-Number: K252633 · 2025-12-23

Decision Date2025-12-23

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

UNITY DX (UDX) is a medical device manufactured by Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2025-12-23 under approval number K252633. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITY DX (UDX)?

UNITY DX (UDX) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Cylite Pty. , Ltd.. The 510(k) number is K252633.

When was UNITY DX (UDX) approved by the FDA?

UNITY DX (UDX) received FDA 510(k) clearance on 2025-12-23, under approval number K252633.

What company makes UNITY DX (UDX)?

UNITY DX (UDX) is manufactured by Cylite Pty. , Ltd..

What is the FDA product code for UNITY DX (UDX)?

The FDA product code for UNITY DX (UDX) is OBO.

Other Devices by Cylite Pty. , Ltd.

K231760HP-OCT (HP-OCT)

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Official Source

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