# K993153: Intralase 600C Laser Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Intra Lase Corp.
- Decided: Dec 17, 1999 after 87 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: 2 generations back to K913697 (1991). 3 ancestors in all.
66 later devices descend from it; 5 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)
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 1.
- K892058: ISL QC 2000, Intelligent Surgical Lasers, Inc. (1989) Summary page 1.

## Most influential descendants
- K013941: Pulsion FS Laser Keratome (2002), 65 descendants of its own
- 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

## 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 IntraLase 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K993153
Methodology: https://510kreport.com/methodology