K243600
- 510(k) number
- K243600
- Device name
- 3nethra neo HD FA; 3nethra neo HD
- Applicant
- Forus Health Pvt.Ltd IN
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2025-08-14
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243600.pdf
Official FDA record: K243600
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.