K230627
- 510(k) number
- K230627
- Device name
- Zilia Ocular FC (ZIL-10002)
- Applicant
- Zilia, Inc. CA
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2023-11-20
- Date received
- 2023-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K230627.pdf
Official FDA record: K230627
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.