# K161012: Easy-Load Lens Delivery System

- Pathway: 510(k) (Special)
- Applicant: Bausch and Lomb, Inc.,
- Decided: Jul 6, 2016 after 86 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132481: Easy-Load Lens Delivery System, Bausch & Lomb (2013) Summary page 4.
- K131958: Bausch & Lomb Injector System, Bausch & Lomb (2014) Summary page 4.

## Indications for use
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

Source page: https://510kreport.com/device/K161012
Methodology: https://510kreport.com/methodology