Cynosure, Inc.

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

Powered laser surgical instrument (GEX) (8) Laser for disruption of adipocyte cells for aesthetic use (PKT) (2) Powered laser surgical instrument with microbeam\fractional output (ONG) (1)

Premarket Exempt

No Yes

Clear

PicoSure - 00841494100001 Catalog Number :

Device Description : Picosure Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Icon - 00841494100018 Catalog Number :

Device Description : Icon Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

Focus Cap Array - 00841494100025 Catalog Number :

Device Description : PicoSure Focus Cap Array

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SculpSure laser assembly - 00841494100032 Catalog Number :

Device Description : SculpSure laser assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PKT

Prescription Use : Yes

Device Count : 1

SculpSure Applicator - 00841494100049 Catalog Number :

Device Description : SculpSure Applicator

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : PKT

Prescription Use : Yes

Device Count : 1

Elite MPX - 00841494100056 Catalog Number :

Device Description : Elite MPX Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Elite+ - 00841494100063 Catalog Number :

Device Description : Elite+ Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Apogee+ - 00841494100070 Catalog Number :

Device Description : Apogee+ Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Cynergy - 00841494100087 Catalog Number :

Device Description : Cynergy Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Cynergy PDL - 00841494100094 Catalog Number :

Device Description : Cynergy PDL, Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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