SYNERON MEDICAL LTD

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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (9) Powered Laser Surgical Instrument (GEX) (9)

Premarket Exempt

No

Clear

eMax - 07290109950013 Catalog Number : AS10812

Device Description : eMax System 115VAC

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

DS applicator - 07290109950020 Catalog Number : AS00099

Device Description : Elos-DS Applicator

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

ST applicator - 07290109950037 Catalog Number : AS45282

Device Description : ST Applicator Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

SR applicator - 07290109950044 Catalog Number : AS00089

Device Description : Elos-SR Applicator

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

SRA applicator - 07290109950051 Catalog Number : AS37432

Device Description : Elos-SR Advanced Applicator

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

AC applicator - 07290109950068 Catalog Number : AS13843

Device Description : Elos-AC Applicator

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

DSL applicator - 07290109950075 Catalog Number : AS34342

Device Description : DSL Applicator, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

LV applicator - 07290109950082 Catalog Number : AS10624

Device Description : LV Applicator, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

LVA applicator - 07290109950099 Catalog Number : AS41302

Device Description : LVA Applicator, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

WRA applicator - 07290109950105 Catalog Number : AS08783

Device Description : WRA Applicator, Packaged

Device Class : 2

Duns Number: 532685716

Premarket Exempt : No

Product Code : GEI, GEX

Prescription Use : No

Device Count : 1

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