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

Hand Piece, external, Packaged, CO2RE Intima - 07290109950501 Catalog Number : AS90244US

Device Description : Hand Piece, external, Packaged, CO2RE Intima

Device Class :

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

F127mm Lens, CO2RE - 07290109950518 Catalog Number : AS76103

Device Description : F127mm Lens, CO2RE

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

VelasmoothPro system - 07290109950532 Catalog Number : FG70271

Device Description : VelasmoothPro System 100V, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

VelasmoothPro system - 07290109950549 Catalog Number : FG70261

Device Description : VelasmoothPro System 115V, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Velasmooth Pro, Large applicator - 07290109950556 Catalog Number : FG70241

Device Description : Large Applicator, VelasmoothPro

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Velasmooth Pro, Small applicator - 07290109950563 Catalog Number : FG70231

Device Description : Small Applicator, VelasmoothPro

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover, LA-16Hr - 07290109950570 Catalog Number : AS75394

Device Description : Repl. Cover, LA-16Hr, VelasmoothPro

Device Class :

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover, SA-4Hr - 07290109950587 Catalog Number : AS75402

Device Description : Repl. Cover, SA-4Hr, VelasmoothPro

Device Class :

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover LA-24Hr - 07290109950594 Catalog Number : AS80242

Device Description : Repl. Cover,(Dark Gray) LA-24Hr, VelaSmooth Pro

Device Class :

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

Repl. Cover , SA-12Hr - 07290109950600 Catalog Number : AS80251

Device Description : Repl. Cover (Dark Gray), SA-12Hr, VelaSmooth Pro

Device Class :

Duns Number: 532685716

Premarket Exempt : No

Product Code : NUV

Prescription Use : No

Device Count : 1

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