EL.EN. SPA

Want to know more about this Organization? Request more information now!

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) (9) Laser, Cellulite Appearance (OYW) (1)

Premarket Exempt

No Yes

Clear

SLT II - 08057017760009 Catalog Number : M094E1

Device Description : The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitti

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : OYW

Prescription Use : Yes

Device Count : 1

DEKA SMARTFILE - 08057017760054 Catalog Number : M077C2

Device Description : The Smartfile medical system is a Nd:YAG laser device for treatment of dental de

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SMARTXIDE - 08057017760078 Catalog Number : M079R1

Device Description : The Smartxide system consists in a carbon dioxide laser (CO2) with 30W of maximu

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SMARTXIDE 50 - 08057017760085 Catalog Number : M079AL1

Device Description : The Smartxide 50 system consists in a carbon dioxide laser (CO2) with 50W of max

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SMART US-20D - 08057017760092 Catalog Number : M079B1

Device Description : The smart US-20D system consists in a carbon dioxide laser (CO2) with 25W of max

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4 - 08057017760108 Catalog Number : M104K1

Device Description : The Synchro Repla:y Excellium 3.4 is a medical laser workstation equipped with a

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SYNCHRO REPLA:Y EXCELLIUM HP - 08057017760115 Catalog Number : M104L1

Device Description : The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SYNCHRO REPLA:Y PREMIUM 1.4.2 - 08057017760122 Catalog Number : M104J1

Device Description : The Synchro Repla:y Premium 1.4.2 is a medical laser workstation equipped with a

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SMARTSKIN+ - 08057017760139 Catalog Number : M079AZ1

Device Description : The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DEKA SMARTXIDE² - 08057017760146 Catalog Number : M103P1

Device Description : The SmartXide² system consists in a carbon dioxide laser (CO2) laser with 60W of

Device Class : 2

Duns Number: 436887608

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 Next