# K101325: Stellaris PC Vision Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 17, 2010 after 97 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844373 (1985). 17 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063331: Bausch & Lomb NGX Microsurgical System, Bausch & Lomb, Inc. (2006) Summary page 2.
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 2.
- K082473: Bausch & Lomb Stellaris Microsurgical System, Bausch & Lomb, Inc. (2009) Summary page 2.

## Most influential descendants
- K133486: Stellaris PC Vision Enhancement System (2014), 7 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K133242: Stellaris Vision Enhancement System (2014), 4 descendants of its own
- 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

## Recalls of this device
- Aug 31, 2012 · Class II · Z-0593-2013: Posterior fluidics modules installed in the system may need to be recalibrated.

## Indications for use
The Bausch & Lomb Stellaris PC 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 phacofragmentation (coaxial or bimanual), irrigation/aspiration, bipolar diathermy, 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/K101325
Methodology: https://510kreport.com/methodology