# K073404: Ifs Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Apr 25, 2008 after 143 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: 7 generations back to K913697 (1991). 29 ancestors in all.
56 later devices descend from it; 5 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 1.
- K063682: Intralase Fusion Laser, Intra Lase Corp. (2007) Summary page 1.
- K032910: Carriazo Pendular, Schwind Eye-Tech-Solutions GmbH & Co. KG (2004) Summary page 1.

## Most influential descendants
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K101006: Wavelight FS200 Laser System Model: FS200 (2010), 21 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 cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty

Source page: https://510kreport.com/device/K073404
Methodology: https://510kreport.com/methodology