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) (5) Powered laser surgical instrument (GEX) (3) Electrode, electrosurgical (JOS) (1) Powered laser surgical instrument with microbeam\fractional output (ONG) (1)

Premarket Exempt

No Yes

Clear

SUCTION COAG. TUBE 6", 3/32" CALIBER - 00841494108496 Catalog Number :

Device Description : SUCTION COAG. TUBE 6", 3/32" CALIBER

Device Class : 2

Duns Number: 780318028

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

PELLEVE S5 GENERATOR, 220-240V - 00841494108502 Catalog Number :

Device Description : PELLEVE S5 GENERATOR, 220-240V

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FlexSure Medium Applicator - 00841494108519 Catalog Number :

Device Description : FlexSure Medium Applicator

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX, GEI

Prescription Use : Yes

Device Count : 1

FlexSure Medium Applicator 10-Pack - 00841494108526 Catalog Number :

Device Description : FlexSure Medium Applicator 10-Pack

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 10

FlexSure Large Applicator - 00841494108533 Catalog Number :

Device Description : FlexSure Large Applicator

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX, GEI

Prescription Use : Yes

Device Count : 1

FlexSure Large Applicator 10-Pack - 00841494108540 Catalog Number :

Device Description : FlexSure Large Applicator 10-Pack

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX, GEI

Prescription Use : Yes

Device Count : 10

LUXY HP, STARLUX 500 - 00841494108557 Catalog Number :

Device Description : LUXY HP, STARLUX 500

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

FlexSure Interface Adapter - 00841494108564 Catalog Number :

Device Description : FlexSure Interface Adapter

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

PrecistionTx Handpiece, 2 Pack - 10841494100374 Catalog Number :

Device Description : PrecistionTx Handpiece, 2 Pack

Device Class :

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 2

Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack - 10841494100398 Catalog Number :

Device Description : Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack

Device Class :

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 10

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