Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
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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
LIGHTSHEER DESIRE, serial all systems with XC handpiece.
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Destined for temporary hair removal, or long-term or permanent hair reduction, by selective application to melanin of the hair follicles. Used for pseudofolliculitis, treatment of varicose veins, benign vascular lesions, angiomas, hemangiomas and telangiectasia
AcuPulse DUO CO2, AcuPulse and AcuScan120, concerning the FemTouch Kit and FemTouch Handpiece systems.
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The CO2 laser can be used effectively in soft tissue removal, incision, ablation, vaporization and coagulation. This CO2 laser system excited by DC (direct current) is designed for various procedures, aesthetic, surgical and general surgery.
GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
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Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.