# K031960: Intralase FS Laser

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Sep 29, 2003 after 96 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913697 (1991). 5 ancestors in all.
61 later devices descend from it; 4 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)
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002)

## 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

## Recalls of this device
- Oct 12, 2011 · Not classified · Z-0167-2012: The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.
- Oct 12, 2011 · Not classified · Z-0165-2012: The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.
- Oct 12, 2011 · Not classified · Z-0166-2012: The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.

## Indications for use
The INTRALASE FS 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.

Source page: https://510kreport.com/device/K031960
Methodology: https://510kreport.com/methodology