FDA-Device2016-06-15Class II
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Ellipse A/S
Hazard
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Sold states
Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Affected count
US - 25
Manufactured in
Agern Alle 11, N/A, Horsholm, N/A, Denmark
Products
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2016Don't want to check this manually?
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