Unity DX (Udx)
FDA 510(k) K252633 · Cylite Pty. , Ltd.
510(k) numberK252633
Submission
- Device name
- Unity DX (Udx)
- Applicant
- Cylite Pty. , Ltd.
Mulgrave, AU - Received
- August 20, 2025
- Decision date
- December 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBO – Tomography, Optical Coherence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Other 510(k)s with product code OBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261019 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 09/11/2026SE |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 05/07/2026SE |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional | Tomey Corporation | 07/18/2025SE |
| K250868 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 05/12/2025SE |
| K240924 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 10/11/2024SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | Topcon Corporation | 07/17/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 07/01/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | Carl Zeiss Meditec, Inc. | 05/17/2024SE |
| K233602 | P200TE (A10700)OBO · Traditional | Optos Plc. | 05/09/2024SE |
More from Optos Plc.
| 510(k) | Device | Decision |
|---|---|---|
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | 03/08/2024SE |
Questions and answers
When was Unity DX (Udx) cleared by the FDA?
Unity DX (Udx) (K252633) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 125 days after the submission was received.
What is the product code of K252633?
The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.