# K261174: RxSight® Insertion Device

- Pathway: 510(k) (Special)
- Applicant: Rxsight, Inc.
- Decided: Jun 10, 2026 after 62 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: 13 generations back to K930320 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K231838: RxSight® Insertion Device (63002), Rxsight, Inc. (2023) Summary page 5.

## 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 intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+(TM), and IOL models validated for use with this device in IOL approved labeling.

Source page: https://510kreport.com/device/K261174
Methodology: https://510kreport.com/methodology