# K191962: Vitra 2

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Dec 5, 2019 after 135 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: 7 generations back to K894841 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122251: Vitra Multispot, Quantel Medical (2013) Summary page 4.

## Indications for use
The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including: • Proliferative and nonproliferative diabetic retinopathy • Choroidal neovascularization • Branch retinal vein occlusion • Treatment of choroidal neovascularization associated with wet Age-related macular degeneration • Retinal tears and detachments • Macular edema

Source page: https://510kreport.com/device/K191962
Methodology: https://510kreport.com/methodology