# K252052: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

- Pathway: 510(k) (Traditional)
- Applicant: Bausch and Lomb, Incorporated
- Decided: Mar 25, 2026 after 267 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: 5 generations back to K932669 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240169: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455), Bausch and Lomb, Incorporated (2024) Summary page 5.
- K153168: Bi-Blade Vitrectomy Cutter, Medical Instrument Development Laboratories (2016) Summary page 5.

## 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 Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Source page: https://510kreport.com/device/K252052
Methodology: https://510kreport.com/methodology