# K133242: Stellaris Vision Enhancement System

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb
- Decided: Feb 14, 2014 after 116 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: 6 generations back to K844373 (1985). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082473: Bausch & Lomb Stellaris Microsurgical System, Bausch & Lomb, Inc. (2009) Summary page 1.
- K063331: Bausch & Lomb NGX Microsurgical System, Bausch & Lomb, Inc. (2006) Summary page 1.
- K101325: Stellaris PC Vision Enhancement System, Bausch & Lomb, Inc. (2010) Summary page 1.

## Most influential descendants
- K170052: Stellaris Elite vision enhancement system (2017), 1 descendant of its own
- K162342: Stellaris Elite Vision Enhancement System (2017), 1 descendant of its own
- 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
- K232084: Stellaris Elite vision enhancement system (2024), 0 descendants of its own

## Indications for use
The Bausch & Lomb Stellaris® Vision Enhancement System device 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, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.

Source page: https://510kreport.com/device/K133242
Methodology: https://510kreport.com/methodology