# K113852: Bausch & Lomb Iol Injector

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Sep 28, 2012 after 274 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: 5 generations back to K930320 (1994). 9 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092023: Naviject SUB2-1P, Model: LP604430, Medicel AG (2009) Summary page 1.
- K063155: Monarch Iii Iol Delivery System, Alcon Manufacturing, Ltd. (2007) Summary page 1.

## Most influential descendants
- K131958: Bausch & Lomb Injector System (2014), 9 descendants of its own
- 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

## Indications for use
The Bausch + Lomb TOL Injector is indicated for folding and injection of Bausch + Lomb lOLs approved for use with this injector.

Source page: https://510kreport.com/device/K113852
Methodology: https://510kreport.com/methodology