Lumenis, Inc.

Model numbers: GA-0040061;, GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066 Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501

Ophthalmic Devices

2

No

FL, IL, MD, CO and TX

Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

Model: GA-0025020

General and Plastic Surgery Devices

2

No

Distributed in the states of NJ, PA, and IL.

Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. || Intended for use in the treatment of ocular pathology.

All assembled units since product release, Part Number: GA-0006700.

Ophthalmic Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.

Array LaserLink, Manufactured by Lumenis, || The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma