K250553
- 510(k) number
- K250553
- Device name
- Tomey Cornea/Anterior Segment OCT (CASIA2)
- Applicant
- Tomey Corporation JP
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2025-07-18
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250553.pdf
Official FDA record: K250553
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.