# K063682: Intralase Fusion Laser

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Feb 9, 2007 after 60 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: 6 generations back to K913697 (1991). 15 ancestors in all.
57 later devices descend from it; 3 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)
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 1.

## Most influential descendants
- 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
- K101626: Lensx Laser System (2010), 30 descendants of its own

## Indications for use
The IntraLase FusionJ Laser is an ophthalmic surgical laser indicated for use in the creation of corneal flaps in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K063682
Methodology: https://510kreport.com/methodology