FDA-Device2016-04-13Class II
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Laserex Systems Inc.
Hazard
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Sold states
Worldwide Distribution - US Distribution
Affected count
72 units plus 2 spare units
Manufactured in
7138 SHADY OAK RD, N/A, EDEN PRAIRIE, MN, United States
Products
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2016Don't want to check this manually?
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