K233911
- 510(k) number
- K233911
- Device name
- VISULAS combi
- Applicant
- Carl Zeiss Meditec, AG DE
- Product code
- HQF — Laser, Ophthalmic
- Decision date
- 2024-09-06
- Date received
- 2023-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
510(k) Summary (official FDA PDF): K233911.pdf
Official FDA record: K233911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.