# K113151: Ifs Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Mar 8, 2012 after 135 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913697 (1991). 61 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 81 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 1.
- K073404: Ifs Laser System, Intra Lase Corp. (2008) Summary page 1.
- K863725: Cataract Diamond Knife, Medical Technology Development Corp. (1986) Summary page 1.

## Most influential descendants
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K120426: Victus Laser Platform (2012), 7 descendants of its own
- K122386: Victus Femtosecond Laser Platform (2013), 6 descendants of its own
- K141852: Ifs Advanced Femtosecond Laser System (2015), 5 descendants of its own
- K132534: Victus Femtosecond Laser Platform (2014), 5 descendants of its own

## Indications for use
The IFS Laser System is an ophthalmic surgical laser indicated for use: * In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea * In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea * In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments * In lamellar keratoplasty and corneal harvesting * In the creation of a lamellar cuttresection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty * In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

Source page: https://510kreport.com/device/K113151
Methodology: https://510kreport.com/methodology