# K161288: LenSX Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Nov 16, 2016 after 191 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: 13 generations back to K913697 (1991). 85 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101626: Lensx Laser System, Lensx Lasers, Inc. (2010) Summary page 5.
- K120732: Lenssx Laser System, Alcon Lensx, Inc. (2012) Summary page 5.
- K123120: Lensx Laser System, Alcon Lensx, Inc. (2012) Summary page 5.

## Most influential descendants
- K163551: LenSx Laser System (2017), 3 descendants of its own
- K173660: LenSx Laser System (2018), 2 descendants of its own
- K243896: LenSx Laser System (8065998162) (2025), 1 descendant of its own
- K252682: LenSx Laser System (8065000944) (2025), 0 descendants of its own

## Indications 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 a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K161288
Methodology: https://510kreport.com/methodology