K250501
- 510(k) number
- K250501
- Device name
- System Sophi
- Applicant
- This AG CH
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2025-11-14
- Date received
- 2025-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250501.pdf
Official FDA record: K250501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.