FDA-Device2013-09-18Class II
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Lumenis, Inc.
Hazard
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Sold states
Distributed in the states of NJ, PA, and IL.
Affected count
3 units
Manufactured in
3959 W 1820 S, N/A, Salt Lake City, UT, United States
Products
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2191-2013Don't want to check this manually?
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