# K181401: RxSight Insertion Device

- Pathway: 510(k) (Traditional)
- Applicant: Rxsight, Inc.
- Decided: Jul 26, 2018 after 58 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: 9 generations back to K930320 (1994). 19 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151102: Bausch + Lomb Injector System, Bausch & Lomb, Inc. (2015) Summary page 4.
- K172228: pioli IOL Delivery System, Ast Products, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K261174: RxSight® Insertion Device (2026), 0 descendants of its own

## Indications for use
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the insertion of the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.

Source page: https://510kreport.com/device/K181401
Methodology: https://510kreport.com/methodology