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Ellipse A/S

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1697-2016Class IIEllipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.May 5, 2016
Z-1698-2016Class IIEllipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.May 5, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunMarch 26, 2020
K180406Ellipse YdunMarch 15, 2018
K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, September 16, 2016
K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse NordlysJuly 7, 2015
K140670ELLIPSE I2PL+/ELLIPSE MULTIFLEX+September 25, 2014
K081408ELLIPSE MULTIFLEXOctober 17, 2008
K072023ELLIPSE JUVIA, MODEL 9EJU7465September 12, 2007