K230350
- 510(k) number
- K230350
- Device name
- VISULAS yag
- Applicant
- Carl Zeiss Meditec, Inc. CA · US
- Product code
- HQF — Laser, Ophthalmic
- Decision date
- 2023-09-22
- Date received
- 2023-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230350.pdf
Official FDA record: K230350
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.