FDA.reportPublic FDA data

Ellipse

Primary DI
05713530000444
Brand
Ellipse
Company
Ellipse A/S
Model
Sirius
Catalog number
9SYS7773
Device description
Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).
Published
2019-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713530000444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713530000444057135300004445713530000444

GMDN Terms#

Term, Definition table
TermDefinition
Intense pulsed light skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4545768808olek@candelamedical.com

Regulatory Flags#

DUNS number
305006145
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713530000314EllipseYdun9SYS78522018-09-18
05713530000420EllipseNordlys9SYS77512019-08-05
05713530000468EllipseYdun9SYS78522019-08-05
05713530000079HRD 6459APP77462021-03-16
05713530000253Nd:YAG Nordlys9APP77502021-03-16
05713530000260Nd:YAG MultiFlex9APP74722021-03-16
05713530000277Frax 15509APP78292021-03-16
05713530000291Frax 15509APP78292021-03-16
05713530000338HRL 6009APP77452021-03-16
05713530000345HRL 6009APP77452021-03-16
05713530000352HRD 6459APP77462021-03-16
05713530000369VL5559APP77472021-03-16
05713530000376PR 5309APP77482021-03-16
05713530000383VLS 5559APP78142021-03-16
05713530000390PRS 5309APP78152021-03-16
05713530000406PL 4009APP77492021-03-16
05713530000451ydun9SYS78522021-03-16
05713530000475Ellipse Nordlys9SYS77512021-03-16
05713530000482Ellipse Nordlys USA9SYS77512021-03-16
05713530000499Ellipse Sirius9SYS77732021-03-16

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Primary DI, Brand, Company table
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