510(k) K261264 · HQC Unit, Phacofragmentation
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
| Applicant | Bausch and Lomb, Saint Louis MO, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Apr 16, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261264
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.