FDA.reportPublic FDA data

Ellipse A/S

Matched from indexed company URL: Ellipse A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051124953005112495Ellipse A/S1N2020-04-25AGERN ALLE 11 HOERSHOLM Region Hovedstaden DK DK-2970

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05713530000314Ellipse - System for skin surface treatment by Laser.+4545768808sales@ellipse.com
05713530000420Ellipse - Multi-modality skin surface treatment system: Intense Pulsed Light (IPL) and Laser device.+4545768808olek@candelamedical.com
05713530000468Ellipse - System for skin surface treatment by Laser.+4545768808olek@candelamedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
643701824029330K180406Ellipse YdunGEX2018-03-15
643701633370295K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEX2016-09-16
643701393442727K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEX2015-07-07
643701566432341K140670ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ONF2014-09-25
643701835321475K081408ELLIPSE MULTIFLEXGEX2008-10-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX42018-03-15
ONF12014-09-25

PMN#

GUDID#