Ellipse A S

FDA Filings

This page includes the latest FDA filings for Ellipse A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005112495
• FEI Number: 3005112495
• Name: Ellipse A/S
• Owner & Operator: Ellipse A/S
• Contact Address: Agern Alle 11 --; Hoersholm DK-84 Region Hovedstaden DK-2970 DK
• Official Correspondent:
  • Ole - Kofod
  • 45-4517-6863-x
• US Agent:
  • Greg Wallender
  • Candela Corporation
  • 508 3580463
  • gregw@candelamedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: AGERN ALLE 11 ; HOERSHOLM Region Hovedstaden, DK-2970 DK
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 05713530000444 Ellipse A/S	Ellipse 9SYS7773	2021-10-19
GUDID 05713530000505 Ellipse A/S	Ellipse Sirius USA	2021-03-24
GUDID 05713530000499 Ellipse A/S	Ellipse Sirius	2021-03-24
GUDID 05713530000482 Ellipse A/S	Ellipse Nordlys USA	2021-03-24
GUDID 05713530000475 Ellipse A/S	Ellipse Nordlys	2021-03-24
GUDID 05713530000451 Ellipse A/S	ydun	2021-03-24
GUDID 05713530000406 Ellipse A/S	PL 400	2021-03-24
GUDID 05713530000390 Ellipse A/S	PRS 530	2021-03-24
GUDID 05713530000383 Ellipse A/S	VLS 555	2021-03-24
GUDID 05713530000376 Ellipse A/S	PR 530	2021-03-24
GUDID 05713530000369 Ellipse A/S	VL555	2021-03-24
GUDID 05713530000352 Ellipse A/S	HRD 645	2021-03-24
GUDID 05713530000345 Ellipse A/S	HRL 600	2021-03-24
GUDID 05713530000338 Ellipse A/S	HRL 600	2021-03-24
GUDID 05713530000291 Ellipse A/S	Frax 1550	2021-03-24
GUDID 05713530000277 Ellipse A/S	Frax 1550	2021-03-24
GUDID 05713530000260 Ellipse A/S	Nd:YAG MultiFlex	2021-03-24
GUDID 05713530000253 Ellipse A/S	Nd:YAG Nordlys	2021-03-24
GUDID 05713530000079 Ellipse A/S	HRD 645	2021-03-24
PMN K192951 Ellipse A/S	Ellipse Frax 1940 For Ellipse Nordlys And Ellipse Ydun	2020-03-26
GUDID 05713530000307 Ellipse A/S	Ellipse 9SYS7852	2018-10-19
GUDID 05713530000246 Ellipse A/S	Ellipse 9SYS7852	2018-07-06
GUDID 05713530000178 Ellipse A/S	Ellipse 9SYS7751	2018-07-06
PMN K180406 | GEX Ellipse A/S	Frax Pro	2018-03-22
PMN K180406 | GEX Ellipse A/S	Ellipse Ydun	2018-03-22
PMN K180406 Ellipse A/S	Ellipse Ydun	2018-03-15
PMN K161162 | GEX Ellipse A/S	Frax 1550 for Ellipse Nordlys system	2016-09-23
PMN K161162 | GEX Ellipse A/S	Ellipse Sirius	2016-09-23
PMN K161162 | GEX Ellipse A/S	Ellipse Nordlys	2016-09-23
PMN K161162 | GEX Ellipse A/S	Ellipse Frax 1550 for Ellipse Nordlys system.	2016-09-23
PMN K161162 ELLIPSE A/S	Frax 1550 For Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	2016-09-16
PMN K150907 | ONF Ellipse A/S	Ellipse Nordlys	2015-07-14
PMN K150907 | GEX Ellipse A/S	Ellipse Nordlys	2015-07-14
PMN K150907 Ellipse A/S	Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra	2015-07-07
PMN K140670 | ONF Ellipse A/S	Ellipse MultiFlex+	2014-11-03
PMN K140670 | ONF Ellipse A/S	Ellipse I2PL+	2014-11-03
PMN K140670 | GEX Ellipse A/S	Ellipse MultiFlex+	2014-11-03
PMN K140670 | GEX Ellipse A/S	Ellipse I2PL+	2014-11-03
PMN K140670 ELLIPSE A/S	ELLIPSE I2PL+/ELLIPSE MULTIFLEX+	2014-09-25
PMN K081408 | GEX Ellipse A/S	Ellipse MultiFlex	2008-12-03
PMN K081408 | GEX Ellipse A/S	Ellipse MultiFlex+	2008-12-03
PMN K081408 ELLIPSE A/S	ELLIPSE MULTIFLEX	2008-10-17
PMN K072023 ELLIPSE A/S	ELLIPSE JUVIA, MODEL 9EJU7465	2007-09-12