# K013941: Pulsion FS Laser Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Feb 27, 2002 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913697 (1991). 4 ancestors in all.
65 later devices descend from it; 7 cite it directly.
0 of 70 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 1.

## Most influential descendants
- K031960: Intralase FS Laser (2003), 61 descendants of its own
- 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
- K033354: Femtec Laser Microkeratome (2004), 52 descendants of its own

## Recalls of this device
- Jul 15, 2003 · Not classified · Z-1124-03: Gantry moves toward patient when 'Home' button is used after procedure.

## Indications for use
The Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a comneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K013941
Methodology: https://510kreport.com/methodology