# K103056: Visulas Trion Laser System with the Vite Option

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Feb 1, 2011 after 109 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: 7 generations back to K894841 (1989). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072514: Visulas Trion, Carl Zeiss Meditec, AG (2007) Summary page 2.
- K100035: Model Visulas 532S Laser with the Vite Option, Carl Zeiss Meditec, AG (2010) Summary page 2.
- K043486: Pascal Photocoagulator, Product-Pascal-01, Topcon Medical Laser Systems, Inc. (2005) Summary page 2.
- K081744: Pascal Synthesis Delivery System, Optimedica Corporation (2008) Summary page 2.
- K091666: Pascal Photocoagulator, Pascal-US, Optimedica Corporation (2009) Summary page 3.
- K092621: Pascal Streamline Photocoagulator, Topcon Medical Laser Systems, Inc. (2009) Summary page 2.

## Indications for use
The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as: Photocoagulation of the retina Trabeculoplasty for treatment of glaucoma Iridotomy for treatment of glaucoma. The VISULAS Trion Laser System with the VITE option is intended for use in multi-spot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including: Proliferative and nonproliferative diabetic retinopathy Macular edema Branch and central retinal vein occlusion Lattice degeneration Retinal tears and detachments Choroidal neovascularization associated with wet age-related macular degeneration.

Source page: https://510kreport.com/device/K103056
Methodology: https://510kreport.com/methodology