Product areas
FDA product code distribution
Ellipse A/S
Country / Region:Denmark (DK)Website:candelamedical.com
510(k) submissions
4
Filtered: GEX
Latest clearance
2020-03-26
Product codes
1
GEX
510(k) submissions
4 total · filtered by GEX
Showing 1–4
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| 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 |
Company profile
- Canonical name
- Ellipse A/S
- Country / Region
- Denmark(DK)
- Website
- candelamedical.com
Predicate manufacturers
Companies whose devices this company cited as predicates
1 manufacturers
- 5
Citing manufacturers
Companies that cited this company's devices as predicates
3 manufacturers
- 5
- 2
- 1