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) (10) Laser, cellulite appearance (OYW) (1) Powered laser surgical instrument with microbeam\fractional output (ONG) (1)

Premarket Exempt

No Yes

Clear

ThermaGuide Cannula for Cellulaze, 250mm - 00841494100469 Catalog Number :

Device Description : ThermaGuide Cannula for Cellulaze, 250mm

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, OYW

Prescription Use : Yes

Device Count : 1

SlimlipoTip 175 mm, EO - 00841494100476 Catalog Number :

Device Description : SlimlipoTip 175 mm, EO

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimlipo, 275mm Tip, EO - 00841494100483 Catalog Number :

Device Description : Slimlipo, 275mm Tip, EO

Device Class :

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimlipo Tip, 100mm Length, EO - 00841494100490 Catalog Number :

Device Description : Slimlipo Tip, 100mm Length, EO

Device Class :

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Affirm 10mm Tip - 00841494100506 Catalog Number :

Device Description : Affirm 10mm Tip

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Affirm, 14mm Tip - 00841494100513 Catalog Number :

Device Description : Affirm, 14mm Tip

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ASSY, 1540 HANDPIECE, ICON - 00841494100520 Catalog Number :

Device Description : ASSY, 1540 HANDPIECE, ICON

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

ASSY, FINAL LASER, PICO300 - 00841494100537 Catalog Number :

Device Description : ASSY, FINAL LASER, PICO300

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Metal Cone, one piece - 00841494100544 Catalog Number :

Device Description : Metal Cone, one piece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Spacer tip, handpiece - 00841494100551 Catalog Number :

Device Description : Spacer tip, handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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