K252348
- 510(k) number
- K252348
- Device name
- Tomey Optical Biometer OA-2000 (OA-2000)
- Applicant
- Tomey Corporation JP
- Product code
- MXK — Device, Analysis, Anterior Segment
- Decision date
- 2025-12-18
- Date received
- 2025-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 4.1 MB · U.S. public domain
Also available from FDA: K252348.pdf
Official FDA record: K252348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.