K261264
- 510(k) number
- K261264
- Device name
- Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+
- Applicant
- Bausch and Lomb MO · US
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2026-05-15
- Date received
- 2026-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261264.pdf
Official FDA record: K261264
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.