K251848
- 510(k) number
- K251848
- Device name
- Pentacam® Cornea OCT
- Applicant
- Oculus Optikgeräte GmbH DE
- Product code
- MXK — Device, Analysis, Anterior Segment
- Decision date
- 2026-03-13
- Date received
- 2025-06-16
- 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: K251848.pdf
Official FDA record: K251848
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.