# K081565: Integre Pro, Model L2RY

- Pathway: 510(k) (Special)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Jul 2, 2008 after 28 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- 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: 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.

## Recalls of this device
- Mar 16, 2023 · Class II · Z-1971-2023: When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get 

## Indications for use
The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology. The Ellex Integre Pro L2RY 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/K081565
Methodology: https://510kreport.com/methodology