# K120732: Lenssx Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Lensx, Inc.
- Decided: Sep 6, 2012 after 181 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913697 (1991). 64 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 77 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 2.
- K993153: Intralase 600C Laser Keratome, Intra Lase Corp. (1999) Summary page 1.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 1.
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 1.
- K073404: Ifs Laser System, Intra Lase Corp. (2008) Summary page 1.
- K101006: Wavelight FS200 Laser System Model: FS200, Alcon Research, Ltd. (2010) Summary page 1.
- K033354: Femtec Laser Microkeratome, 20/10 Perfect Vision Optische Gerate GmbH (2004) Summary page 1.
- K100253: Visumax  Laser Keratome, Carl Zeiss Meditec, AG (2010) Summary page 1.

## Most influential descendants
- K132534: Victus Femtosecond Laser Platform (2014), 5 descendants of its own
- K123120: Lensx Laser System (2012), 5 descendants of its own
- K161288: LenSX Laser System (2016), 4 descendants of its own
- K163551: LenSx Laser System (2017), 3 descendants of its own
- K141379: Victus Femtosecond Laser Platform (2015), 3 descendants of its own

## Recalls of this device
- Apr 14, 2016 · Class II · Z-1688-2016: Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) 

## Indications for use
The LenSx Laser System is indicated for use: * In the creation of corneal cuts/incisions, 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 lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty. * 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/K120732
Methodology: https://510kreport.com/methodology