# K002890: Intralase 600C Laser Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Aug 9, 2001 after 328 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
No predicates in its family tree.
61 later devices descend from it; 4 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041893: Intralase FS Laser (2005), 60 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
- K082947: Lensx 550 Laser System (2009), 51 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.

Source page: https://510kreport.com/device/K002890
Methodology: https://510kreport.com/methodology