# K231838: RxSight® Insertion Device (63002)

- Pathway: 510(k) (Traditional)
- Applicant: Rxsight, Inc.
- Decided: Aug 15, 2023 after 54 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: 12 generations back to K930320 (1994). 22 ancestors in all.
1 later device descends 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)
- K231466: RxSight Insertion Device, Rxsight, Inc. (2023) Summary page 4.
- K172228: pioli IOL Delivery System, Ast Products, Inc. (2017) Summary page 4.

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

## Indications for use
The RxSight® Insertion Device (Model 63002) 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 (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.

Source page: https://510kreport.com/device/K231838
Methodology: https://510kreport.com/methodology