# K111460: Opto Hyalus Green Laser

- Pathway: 510(k) (Traditional)
- Applicant: Opto Eletronica S/A
- Decided: Aug 20, 2012 after 452 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031665: Iris Medical Oculight GL/GLX Laser Systems, Iridex Corp (2003) Summary page 2.

## Indications for use
The Opto Hyalus Green Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition and treatment: * Retinal photocoagulation, panretinal photocoagulation and intravitreal endlophotocoagulation of vascular and structural abnormalities of the retina and choroids, including: Proliferative and non proliferative diabetic retinopathy Choroidal neovascularization Branch retinal vein occlusion The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments * Iridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K111460
Methodology: https://510kreport.com/methodology