K233398
- 510(k) number
- K233398
- Device name
- Faros Surgical System
- Applicant
- Oertli Instrumente AG CH
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2024-06-27
- Date received
- 2023-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233398.pdf
Official FDA record: K233398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.