# K192005: Bausch + Lomb PreVue Inserter for enVista Preloaded

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 4, 2019 after 67 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: 7 generations back to K930320 (1994). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113852: Bausch & Lomb Iol Injector, Bausch & Lomb, Inc. (2012) Summary page 4.
- K131958: Bausch & Lomb Injector System, Bausch & Lomb (2014) Summary page 4.

## Most influential descendants
- K242389: EyeGility™ Inserter for Preloaded enVista IOLs (2024), 0 descendants of its own

## Indications for use
The Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

Source page: https://510kreport.com/device/K192005
Methodology: https://510kreport.com/methodology