# K041598: Laserex, Model LP4532

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Oct 6, 2004 after 114 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.
19 later devices descend from it; 1 cites it directly.
0 of 20 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
- K062624: Next Generation Laser (2007), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K161794: CENTURION Vision System (Active SentryTM) (2017), 3 descendants of its own

## Recalls of this device
- Jun 13, 2007 · Not classified · Z-0286-2008: Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.

## Indications for use
The Laserex LP4532 Ophthalmic Laser is intended for use in the treatment of ocular pathology. The LP4532 is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: retinal photocoagulation, panretinal photocoagulation and intravitreal treatment of vascular and structural abnormalities including retinal tears and holes, proliferative diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, age-related macular degeneration, retinal tears and detachments, retinopathy of prematurity, macular grid and macular focal; iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma and open-angle glaucoma.

Source page: https://510kreport.com/device/K041598
Methodology: https://510kreport.com/methodology