# K041893: Intralase FS Laser

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Jul 29, 2005 after 381 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: 3 generations back to K954058 (1995). 6 ancestors in all.
60 later devices descend from it; 7 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981063: Automated Corneal Trephine, Laser Center Dev. Corp. (1998) Summary page 1.
- K013151: Asmotom Automated Trephine System, Bkg Opthalmics USA, Inc. (2001) Summary page 1.
- K002890: Intralase 600C Laser Keratome, Intra Lase Corp. (2001) Summary page 1.

## Most influential descendants
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 (2006), 58 descendants of its own
- 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

## 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 intial 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 the 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 cornea 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/K041893
Methodology: https://510kreport.com/methodology