K253039
- 510(k) number
- K253039
- Device name
- AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
- Applicant
- Topcon Corporation JP
- Product code
- HKX — Tonometer, Ac-Powered
- Decision date
- 2025-11-07
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253039.pdf
Official FDA record: K253039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.