# K111213: Vision One Laser System

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Inc.
- Decided: Jul 25, 2011 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894841 (1989). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K130195: Scanning Laserlink (2013), 0 descendants of its own

## Recalls of this device
- Aug 19, 2013 · Class II · Z-2191-2013: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

## Indications for use
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal. photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy Choroidal. neovascultarization Branch retinal, vein occlusion Retinal tears and detachments Retinopathy of prematurity Iridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K111213
Methodology: https://510kreport.com/methodology