# K062624: Next Generation Laser

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Nov 5, 2007 after 426 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: 5 generations back to K933880 (1994). 21 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems, Alcon Laboratories (1996) Summary page 1.
- K041598: Laserex, Model LP4532, Ellex Medical Pty, Ltd. (2004) Summary page 1.
- K031665: Iris Medical Oculight GL/GLX Laser Systems, Iridex Corp (2003) Summary page 1.

## Most influential descendants
- 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
- K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula (2011), 3 descendants of its own

## Indications for use
The NGL is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: * Retinal Photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative retinopathy (including diabetic); - Choroidal neovascularization secondary to age-related macular degeneration; - Retinal tears and detachments; - Macular Edema; - Retinopathy of prematurity; - Choroidal neovascularization; - Leaking microaneurysms. * Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG), Acute Angle Closure Glaucoma (AACG), and Refractory Glaucoma. * Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. • And other laser treatments including: - Internal sclerostomy; - Lattice degeneration; - Central and Branch Retinal Vein Occlusion; - Suturelysis; - Vascular and pigmented skin lesions.

Source page: https://510kreport.com/device/K062624
Methodology: https://510kreport.com/methodology