FDA-Device2016-05-25Class II
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenter
Medtronic Navigation, Inc.
Hazard
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Sold states
Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Affected count
120
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1672-2016Don't want to check this manually?
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