K252120
- 510(k) number
- K252120
- Device name
- Fundus On Phone Non Mydriatic (FOP NM-10)
- Applicant
- Remidio Innovative Solutions Private Limited IN
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2025-12-12
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252120.pdf
Official FDA record: K252120
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.