K231760
- 510(k) number
- K231760
- Device name
- HP-OCT (HP-OCT)
- Applicant
- Cylite Pty. , Ltd. AU
- Product code
- HJO — Biomicroscope, Slit-Lamp, Ac-Powered
- Decision date
- 2024-03-08
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K231760.pdf
Official FDA record: K231760
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.