Ellipse A/S

Ellipse A/S

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1)

Premarket Exempt

No

Clear

HRD 645 - 05713530000079 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Ellipse - 05713530000178 Catalog Number : 9SYS7751

Device Description : Multi-modality skin surface treatment system: Intense Pulsed Light (IPL) and Laser device.

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Nd:YAG Nordlys - 05713530000253 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Nd:YAG MultiFlex - 05713530000260 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : No

Device Count : 1

Frax 1550 - 05713530000277 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Frax 1550 - 05713530000291 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Ellipse - 05713530000307 Catalog Number : 9SYS7852

Device Description : System for skin surface treatment by fractional Laser.

Device Class :

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Ellipse - 05713530000314 Catalog Number : 9SYS7852

Device Description : System for skin surface treatment by Laser.

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HRL 600 - 05713530000338 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HRL 600 - 05713530000345 Catalog Number :

Device Class : 2

Duns Number: 305006145

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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