# K162342: Stellaris Elite Vision Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch+Lomb
- Decided: Mar 24, 2017 after 214 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K844373 (1985). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133486: Stellaris PC Vision Enhancement System, Bausch & Lomb (2014) Summary page 4.
- K133242: Stellaris Vision Enhancement System, Bausch & Lomb (2014) Summary page 4.

## Most influential descendants
- 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™+ (2026), 0 descendants of its own

## Recalls of this device
- Aug 8, 2018 · Class II · Z-3269-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3276-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3275-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3273-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3270-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3265-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3271-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3277-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3267-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3266-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3272-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3268-2018: The back cap separates from the body of the vitrectomy cutter.
- Aug 8, 2018 · Class II · Z-3274-2018: The back cap separates from the body of the vitrectomy cutter.

## 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.

Source page: https://510kreport.com/device/K162342
Methodology: https://510kreport.com/methodology