K252633
- 510(k) number
- K252633
- Device name
- UNITY DX (UDX)
- Applicant
- Cylite Pty. , Ltd. AU
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2025-12-23
- Date received
- 2025-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252633.pdf
Official FDA record: K252633
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.