# K252682: LenSx Laser System (8065000944)

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Sep 24, 2025 after 30 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K913697 (1991). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243896: LenSx Laser System (8065998162), Alcon Laboratories, Inc. (2025) Summary page 6.

## Indications for use
The LenSx Laser system is indicated for use: * In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. * In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery. * In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. * In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

Source page: https://510kreport.com/device/K252682
Methodology: https://510kreport.com/methodology