# K242389: EyeGility™ Inserter for Preloaded enVista IOLs

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Oct 10, 2024 after 59 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930320 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192005: Bausch + Lomb PreVue Inserter for enVista Preloaded, Bausch & Lomb, Inc. (2019) Summary page 5.
- K113852: Bausch & Lomb Iol Injector, Bausch & Lomb, Inc. (2012) Summary page 5.

## Indications for use
The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

Source page: https://510kreport.com/device/K242389
Methodology: https://510kreport.com/methodology