# K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Mar 16, 2006 after 164 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K103547: Lightlas Multi-Wavelength Medical Laser System (2011), 2 descendants of its own
- K152688: LightLas Multi-Wavelength Medical Laser System (2016), 0 descendants of its own
- K124043: Lightlas Family of Multi-Wavelength Medical Laser System (2013), 0 descendants of its own
- K081565: Integre Pro, Model L2RY (2008), 0 descendants of its own
- K080423: Integre, Model LP581 (2008), 0 descendants of its own

## Recalls of this device
- Feb 1, 2016 · Class II · Z-1270-2016: The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
- Jun 13, 2007 · Not classified · Z-0287-2008: Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.

## Indications for use
The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology. The Laserex Duo 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/K052777
Methodology: https://510kreport.com/methodology