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FDA 510(k)

UNITY DX (UDX)

K-Number: K252633 · 2025-12-23

ApplicantCylite Pty. , Ltd.
Decision Date2025-12-23
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNITY DX (UDX) is the device name listed in this FDA 510(k) record. The listed applicant is Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) 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. The listed applicant is Cylite Pty. , Ltd.. The 510(k) number is K252633.

When did UNITY DX (UDX) receive FDA 510(k) clearance?

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

Who is the listed applicant for UNITY DX (UDX)?

The FDA 510(k) record lists Cylite Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cylite Pty. , Ltd. as applicant

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.

K231760HP-OCT (HP-OCT)

Related Devices (Code: OBO)

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.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemTopcon Corporation

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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