# K142398: Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Jul 14, 2015 after 321 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
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.

## 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 Ellex Integre Pro Scan is indicated for use 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 nonpraoliferative diabetic retinopathy; - choroidal neovascularization; - retinal vein occlusion; - wet age-related macular degeneration; - retinal tears and detachments; - retinopathy of prematurity; e [ridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K142398
Methodology: https://510kreport.com/methodology