# K072514: Visulas Trion

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Sep 21, 2007 after 14 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K894841 (1989). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013402: Visulas 532S, Carl Zeiss, Inc. (2001) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K042785: Multi Color Laser Photocoagulator, Model MC-300, Nidek, Inc. (2004) Summary page 1.

## Most influential descendants
- K103056: Visulas Trion Laser System with the Vite Option (2011), 0 descendants of its own

## Indications for use
The VISULAS Trion is intended for use in photocoagulating 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 laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Source page: https://510kreport.com/device/K072514
Methodology: https://510kreport.com/methodology