K251353
- 510(k) number
- K251353
- Device name
- Eyer 2
- Applicant
- Phelcom Technologies BR
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2026-01-16
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K251353.pdf
Official FDA record: K251353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.