K252633 is an FDA 510(k) clearance for the UNITY DX (UDX). This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Cylite Pty. , Ltd. (Mulgrave, AU). The FDA issued a Cleared decision on December 23, 2025, 125 days after receiving the submission on August 20, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K252633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |