# Ellipse A/S

- Location (FDA's records): Hoersholm, DK
- FDA decisions: 7 (2007–2020): 7 510(k) clearances
- Product codes: GEX (6), ONF (1)
- 510(k) review time since 2016: median 144 days, against 90 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 19 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 3 (https://510kreport.com/company/lumenis)
- Danish Dermatologic Development A/S: 2 (https://510kreport.com/company/danish-dermatologic-development-a-s)
- Solta Medical, Inc.: 2 (https://510kreport.com/company/solta-medical)
- Palomar Medical Products, Inc.: 1 (https://510kreport.com/company/palomar-medical-products)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)

## Firms that cite its devices most
- M&T S.R.L.: 2 (https://510kreport.com/company/m-t)
- Candela Corp.: 1 (https://510kreport.com/company/candela)

## Its most-cited devices
- K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2015), cited by 2
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2016), cited by 2
- K140670: Ellipse I2PL+/Ellipse Multiflex+ (2014), cited by 1
- K192951: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (2020), cited by 1
- K081408: Ellipse Multiflex (2008), cited by 1

## Recent decisions
- K192951: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (Mar 26, 2020)
- K180406: Ellipse Ydun (Mar 15, 2018)
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (Sep 16, 2016)
- K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (Jul 7, 2015)
- K140670: Ellipse I2PL+/Ellipse Multiflex+ (Sep 25, 2014)
- K081408: Ellipse Multiflex (Oct 17, 2008)
- K072023: Ellipse Juvia, Model 9EJU7465 (Sep 12, 2007)

Source page: https://510kreport.com/company/ellipse-a-s