# K892058: ISL QC 2000

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Surgical Lasers, Inc.
- Decided: Jun 15, 1989 after 78 days
- Product code: LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla)
- Device class: 2
- Regulation: 21 CFR 886.4392
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
0 of 68 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
- K993153: Intralase 600C Laser Keratome (1999), 66 descendants of its own
- 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

Source page: https://510kreport.com/device/K892058
Methodology: https://510kreport.com/methodology