# K992824: Laserex ND:Yag Ophthalmic Laser (LQ2106), Alcon ND:Yag Ophthalmic Laser (3000LE), Laserex ND:Yag Ophthalmic Laser, Model

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Nov 17, 1999 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indications for use for the above product family is: * Iridectomy/Iridotomy. * Posterior Capsulotomy. * Posterior Membranectomies.

Source page: https://510kreport.com/device/K992824
Methodology: https://510kreport.com/methodology