# K261264: 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™+

- Pathway: 510(k) (Special)
- Applicant: Bausch and Lomb
- Decided: May 15, 2026 after 29 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K844373 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162342: Stellaris Elite Vision Enhancement System, Bausch+Lomb (2017) Summary page 7.

## Indications for use
The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries.

Source page: https://510kreport.com/device/K261264
Methodology: https://510kreport.com/methodology