K252052
- 510(k) number
- K252052
- Device name
- Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- Applicant
- Bausch and Lomb, Incorporated MO · US
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2026-03-25
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252052.pdf
Official FDA record: K252052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.