# K173660: LenSx Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Mar 27, 2018 after 118 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: 15 generations back to K913697 (1991). 93 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163551: LenSx Laser System, Alcon Laboratories, Inc. (2017) Summary page 5.
- K141852: Ifs Advanced Femtosecond Laser System, Amo Manufacturing USA, LLC (2015) Summary page 5.
- K141476: Wavelight FS200 Laser System, Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
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 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/K173660
Methodology: https://510kreport.com/methodology