Cynosure, Inc.

Address:5 CARLISLE RD,Westford,MA,01886,US

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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) (6) Massager, vacuum, radio frequency induced heat (PBX) (4) Powered laser surgical instrument (GEX) (2) Electrode, electrosurgical (JOS) (1) Electrosurgical patient return electrode (ODR) (1)

Premarket Exempt

No Yes

Clear

2940 HP, Artisan, RFB - 00841494108380 Catalog Number :

Device Description : 2940 HP, Artisan, RFB

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Upgrade, Final TempSure System, Aesth&Surgical - 00841494108397 Catalog Number :

Device Description : Upgrade, Final TempSure System, Aesth&Surgical

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ASSY, Head, Massage, Cellulite, 60mm, TempSure - 00841494108403 Catalog Number :

Device Description : ASSY, Head, Massage, Cellulite, 60mm, TempSure

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

ASSY, Handpiece, 60mm, TempSure - 00841494108410 Catalog Number :

Device Description : ASSY, Handpiece, 60mm, TempSure

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

ASSY, 60MM Body Accessory Kit, TempSure - 00841494108427 Catalog Number :

Device Description : ASSY, 60MM Body Accessory Kit, TempSure

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX, GEI

Prescription Use : Yes

Device Count : 1

EXTRA-LARGE GROUNDING PAD - 00841494108434 Catalog Number :

Device Description : EXTRA-LARGE GROUNDING PAD

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ODR

Prescription Use : Yes

Device Count : 1

ASSY, Full Body Kit With 60mm Kit - 00841494108441 Catalog Number :

Device Description : ASSY, Full Body Kit With 60mm Kit

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

SURGITRON 4.0 DUAL RF/120 IEC 220V - 00841494108465 Catalog Number :

Device Description : SURGITRON 4.0 DUAL RF/120 IEC 220V

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SURGITRON 4.0 DUAL RF/90 IEC 220-240V - 00841494108472 Catalog Number :

Device Description : SURGITRON 4.0 DUAL RF/90 IEC 220-240V

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SUCTION COAG TUBE 3 3/4" , 3/32" CALIBER - 00841494108489 Catalog Number :

Device Description : SUCTION COAG TUBE 3 3/4" , 3/32" CALIBER

Device Class : 2

Duns Number: 780318028

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

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