# K133486: Stellaris PC Vision Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb
- Decided: Mar 12, 2014 after 119 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844373 (1985). 20 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101325: Stellaris PC Vision Enhancement System, Bausch & Lomb, Inc. (2010) Summary page 1.
- K022760: Millennium Microsurgical System, Bausch & Lomb, Inc. (2002) Summary page 1.
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 1.

## Most influential descendants
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- 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

## Recalls of this device
- Nov 4, 2014 · Class II · Z-0863-2015: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- Nov 4, 2014 · Class II · Z-0864-2015: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- Nov 4, 2014 · Class II · Z-0862-2015: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

## Indications for use
The Bausch & Lomb StellarisPC 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 binianual irrigation/aspiration, bipolar coagulation, vitrectomny, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty.

Source page: https://510kreport.com/device/K133486
Methodology: https://510kreport.com/methodology