# K080423: Integre, Model LP581

- Pathway: 510(k) (Special)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Mar 11, 2008 after 25 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052777 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D, Ellex Medical Pty, Ltd. (2006) Summary page 2.

## Indications for use
The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: * Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration; - retinal tears and detachments; - retinopathy of prematurity; * Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K080423
Methodology: https://510kreport.com/methodology