Identifiers
- 510(k) Number
- K252633 FDA 510(k)
- FDA Product Code
- OBO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Unity DX (UDX) is an Optical Coherence Tomography (OCT) device, classified under the nomenclature for ophthalmic imaging. It performs high-resolution, cross-sectional imaging of the retina and anterior segment to assess ocular structures, aiding in the diagnosis and monitoring of retinal diseases, glaucoma, and other ophthalmic conditions.
This device is supplied as a reusable medical instrument and is intended for use in clinical ophthalmology settings. It operates under FDA 510(k) clearance (K252633) and MDR authorisation, adhering to regulatory standards for Class 2 devices under product code OBO. The Unity DX (UDX) is designed for compatibility with standard ophthalmic examination environments and is not indicated for MRI use.
Frequently asked questions
What types of ocular conditions can the Unity DX (UDX) help diagnose or monitor, and how does it do this?
The Unity DX (UDX) is an Optical Coherence Tomography (OCT) device designed to provide high-resolution cross-sectional imaging of the retina and anterior segment. This imaging aids clinicians in diagnosing and monitoring retinal diseases, glaucoma, and other ophthalmic conditions by allowing detailed visualization of ocular structures, enabling precise assessments and longitudinal tracking of changes.
Is the Unity DX (UDX) a single-use or reusable device, and what does this mean for clinical workflows?
The Unity DX (UDX) is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in clinical ophthalmology settings after proper cleaning, disinfection, and maintenance. This design supports efficient workflows in busy ophthalmic practices, as it avoids the need for disposable replacements between patients, though adherence to manufacturer guidelines for reprocessing is critical to ensure safety and performance.
What regulatory pathways has the Unity DX (UDX) followed, and what does this mean for its use in clinical settings?
The Unity DX (UDX) has obtained FDA 510(k) clearance (K252633) under the Traditional pathway and MDR authorization in the European market. This classification as a Class 2 device under product code OBO (Ophthalmic Imaging) indicates it has undergone rigorous review by regulatory authorities to ensure safety and effectiveness for its intended use in ophthalmic imaging. Clinicians can rely on these approvals as evidence of compliance with stringent standards.
Are there specific models or variations of the Unity DX (UDX) available, and how might this affect compatibility with existing ophthalmic equipment?
The Unity DX (UDX) is associated with multiple FEI numbers (e.g., 3004441848, 3002807782, etc.), which may correspond to different configurations, software versions, or regional adaptations of the device. While the exact variations aren’t detailed here, these identifiers suggest the device may offer flexibility in features or compatibility with different clinical setups. Clinicians should verify compatibility with their existing ophthalmic examination environments, particularly regarding software integration and physical dimensions, before adoption.
What precautions should clinicians take when storing or maintaining the Unity DX (UDX) to ensure optimal performance and longevity?
Though specific storage instructions aren’t detailed here, as a reusable Class 2 device, the Unity DX (UDX) likely requires protection from environmental contaminants, extreme temperatures, and physical damage. Manufacturers typically recommend following protocols for cleaning, disinfection, and calibration to maintain accuracy and reliability. Clinicians should consult the device’s user manual for detailed guidance on storage conditions, maintenance schedules, and reprocessing procedures to uphold regulatory compliance and performance standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: UNITY DX (UDX) (K252633) — FDA 510(k) | Innolitics, K252633 FDA 510 (k) - UNITY DX (UDX) | Cylite Pty. , Ltd., UNITY DX (UDX) 510 (k) K252633 - FDA.report, Cylite Pty. , Ltd. FDA 510 (k) Products - Latest 2025
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252633 | Class II | Active |
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Manufacturer
- Manufacturer
- Cylite Pty Ltd
- FDA Applicant
- Cylite Pty. , Ltd.
Sources (2)
- FDA 510(k) K252633 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026