Cynosure, Inc.

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

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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) Powered laser surgical instrument with microbeam\fractional output (ONG) (1)

Premarket Exempt

No Yes

Clear

Max Ys Handpiece - 00841494100308 Catalog Number :

Device Description : Max Ys Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

585nm Dye Hanpiece, Gold - 00841494100315 Catalog Number :

Device Description : 585nm Dye Hanpiece, Gold

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

650nm Dye Handpiece, Red - 00841494100322 Catalog Number :

Device Description : 650nm Dye Handpiece, Red

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

585nm Revlite SI Dye Handpiece, Gold - 00841494100339 Catalog Number :

Device Description : 585nm Revlite SI Dye Handpiece, Gold

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

650nm Revlite SI Dye Handpiece, Red - 00841494100346 Catalog Number :

Device Description : 650nm Revlite SI Dye Handpiece, Red

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD - 00841494100353 Catalog Number :

Device Description : ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300 - 00841494100360 Catalog Number :

Device Description : ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 3

ThermaGuide Cannula for Smartlipo, 600u fiber, 150mm - 00841494100438 Catalog Number :

Device Description : ThermaGuide Cannula for Smartlipo, 600u fiber, 150mm

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm - 00841494100445 Catalog Number :

Device Description : ThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ThermaGuide Cannula for SideLaze800, 150mm - 00841494100452 Catalog Number :

Device Description : ThermaGuide Cannula for SideLaze800, 150mm

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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