SYNERON MEDICAL LTD

Address:Industrial Zone,YOKNEAM, ILLIT Northern,IL

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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

Massager, Vacuum, Light Induced Heating (NUV) (8) Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

Clear

Vsmooth Applicator - 07290109950259 Catalog Number : FG00101

Device Description : Vsmooth Applicator (LA), Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Vcontour Applicator - 07290109950266 Catalog Number : FG00111

Device Description : Vcontour Applicator (SA) ,Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Lens, Gold & Silver - 07290109950273 Catalog Number : AS92041

Device Description : Lens, Gold & Silver Assy, CO2RE

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Intima Accessories Kit, CO2RE - 07290109950280 Catalog Number : KT77002US

Device Description : Intima Accessories Kit, CO2RE

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Vela Shape II system - 07290109950303 Catalog Number : FG70321

Device Description : Vela Shape II System 115V, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Vela Shape II system - 07290109950310 Catalog Number : FG70331

Device Description : Vela Shape II System 100V, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Vsmooth Applicator - 07290109950327 Catalog Number : FG70341

Device Description : Vsmooth Applicator (LA), VelaShape II

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Vcontour Applicator - 07290109950334 Catalog Number : FG70351

Device Description : Vcontour Applicator (SA), VelaShape II

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover (Grey), LA-1Hr, VelaShape II - 07290109950341 Catalog Number : AS74686

Device Description : Repl. Cover (Grey), LA-1Hr, VelaShape II

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover - 07290109950358 Catalog Number : AS74672

Device Description : Repl. Cover (Grey), SA-1Hr, VelaShape II

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

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