# K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Aug 16, 2006 after 184 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: 5 generations back to K913697 (1991). 14 ancestors in all.
58 later devices descend from it; 6 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993153: Intralase 600C Laser Keratome, Intra Lase Corp. (1999) Summary page 2.
- K001211: Modification to Intralase 600C Laser Keratome, Intra Lase Corp. (2000) Summary page 2.
- K002890: Intralase 600C Laser Keratome, Intra Lase Corp. (2001) Summary page 2.
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002) Summary page 2.
- K031960: Intralase FS Laser, Intra Lase Corp. (2003) Summary page 2.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 2.

## Most influential descendants
- K063682: Intralase Fusion Laser (2007), 57 descendants of its own
- K073404: Ifs Laser System (2008), 56 descendants of its own
- 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

## Indications for use
The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use: 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 corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the comea; 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/K060372
Methodology: https://510kreport.com/methodology