Ellipse A/S

Country / region:Denmark (DK)

510(k) submissions

Latest clearance

2020-03-26

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

4 total

K number	Device name	Product code	Class	Decision date
K192951	Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun	GEX	Class 2	2020-03-26
K180406	Ellipse Ydun	GEX	Class 2	2018-03-15
K161162	Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	GEX	Class 2	2016-09-16
K150907	Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	GEX	Class 2	2015-07-07

K130193
—
—
Not ingested
K150907
—
—
Not ingested
K161162
—
—
Not ingested
K180406
—
—
Not ingested
K161162
—
—
Not ingested
K080932
—
—
Not ingested
K130193
—
—
Not ingested
K142376
—
—
Not ingested
K150907
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Ellipse A/S
K033461
—
—
Not ingested
K122493
—
—
Not ingested
K140670
—
—
Not ingested

Ellipse A/S references 12 predicate/reference devices

K212492
Frax 1940 for Nordlys and Frax Pro
Candela Corporation
Not ingested
K192951
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Ellipse A/S
Not ingested
K192951
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Ellipse A/S
Not ingested
K192951
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Ellipse A/S
Not ingested
K192856
MT One
M&T S.R.L.
K192856
MT One
M&T S.R.L.
K180406
Ellipse Ydun
Ellipse A/S
Not ingested
K161162
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Ellipse A/S

8 submissions cite Ellipse A/S as a predicate