K240169
- 510(k) number
- K240169
- Device name
- Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
- Applicant
- Bausch and Lomb, Incorporated MO · US
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2024-07-26
- Date received
- 2024-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
510(k) Summary (official FDA PDF): K240169.pdf
Official FDA record: K240169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.