# K240169: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

- Pathway: 510(k) (Traditional)
- Applicant: Bausch and Lomb, Incorporated
- Decided: Jul 26, 2024 after 186 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K252052: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K240169
Methodology: https://510kreport.com/methodology