# K100035: Model Visulas 532S Laser with the Vite Option

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Mar 17, 2010 after 70 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: 6 generations back to K894841 (1989). 26 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 31 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 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). Our reading of the summary gave K091966, FDA’s number for Angiosculpt Pta Scoring Balloon Catheter, Models… (Angioscore, Inc.). Corrected to the number one digit away that FDA lists under the company the summary names beside it.
- K092621: Pascal Streamline Photocoagulator, Topcon Medical Laser Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K181682: VISULAS green (2019), 2 descendants of its own
- K232051: VISULAS green (2023), 1 descendant of its own
- K233911: VISULAS combi (2024), 0 descendants of its own
- K103056: Visulas Trion Laser System with the Vite Option (2011), 0 descendants of its own

## Indications for use
The VISULAS 532s Laser System with the VITE option is intended for use in 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

Source page: https://510kreport.com/device/K100035
Methodology: https://510kreport.com/methodology