# K131958: Bausch & Lomb Injector System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb
- Decided: Jan 9, 2014 after 196 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: 6 generations back to K930320 (1994). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 20 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 1.
- K063155: Monarch Iii Iol Delivery System, Alcon Manufacturing, Ltd. (2007) Summary page 1.

## Most influential descendants
- K151102: Bausch + Lomb Injector System (2015), 5 descendants of its own
- K181401: RxSight Insertion Device (2018), 4 descendants of its own
- K192926: RxSight Insertion Device (2020), 3 descendants of its own
- K231466: RxSight Insertion Device (2023), 2 descendants of its own
- K231838: RxSight® Insertion Device (63002) (2023), 1 descendant of its own

## Indications for use
The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.

Source page: https://510kreport.com/device/K131958
Methodology: https://510kreport.com/methodology