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

Massager, vacuum, radio frequency induced heat (PBX) (6) Electrosurgical, cutting & coagulation & accessories (GEI) (5)

Premarket Exempt

No Yes

Clear

Pelleve GlideSafe 10MM HP, 1PC - 00841494108120 Catalog Number :

Device Description : Pelleve GlideSafe 10MM HP, 1PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Pelleve GlideSafe 15MM HP, 1PC - 00841494108144 Catalog Number :

Device Description : Pelleve GlideSafe 15MM HP, 1PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Pelleve GlideSafe 20MM HP, 1PC - 00841494108168 Catalog Number :

Device Description : Pelleve GlideSafe 20MM HP, 1PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Pelleve GlideSafe 7.5MM HP, 1PC - 00841494108182 Catalog Number :

Device Description : Pelleve GlideSafe 7.5MM HP, 1PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

PelleFirm 25MM Handpiece, 1 PC - 00841494108212 Catalog Number :

Device Description : PelleFirm 25MM Handpiece, 1 PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

PelleFirm 25MM HP, 3-pack - 00841494108229 Catalog Number :

Device Description : PelleFirm 25MM HP, 3-pack

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

PelleFirm 30MM Handpiece, 1 PC - 00841494108236 Catalog Number :

Device Description : PelleFirm 30MM Handpiece, 1 PC

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

PelleFirm 30MM HP, 3-pack - 00841494108243 Catalog Number :

Device Description : PelleFirm 30MM HP, 3-pack

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

PelleFirm VariPack - 00841494108250 Catalog Number :

Device Description : PelleFirm VariPack

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

RFB, ASSY, FINAL TEMPSURE SYSTEM - 00841494108267 Catalog Number :

Device Description : RFB, ASSY, FINAL TEMPSURE SYSTEM

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI, PBX

Prescription Use : Yes

Device Count : 1

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