# K201909: RxSight Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Rxsight, Inc.
- Decided: Sep 10, 2020 after 63 days
- Product code: HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 886.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872136 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872136: 12.5MM Peyman Wide Field Yag Laser Lens, Ocular Instruments, Inc. (1987) Summary page 4.

## Indications for use
The RxSight Contact Lens is indicated for visualization and treatment in the anterior segment of the eye.

Source page: https://510kreport.com/device/K201909
Methodology: https://510kreport.com/methodology