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) (5) Powered laser surgical instrument (GEX) (5) Powered laser surgical instrument with microbeam\fractional output (ONG) (3)

Premarket Exempt

No Yes

Clear

Pelleve Quick Connect Cable - 00841494108281 Catalog Number :

Device Description : Pelleve Quick Conenct Cable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

10mm GlideSafe HP (3) and Cable - 00841494108298 Catalog Number :

Device Description : 10mm GlideSafe HP (3) and Cable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

15mm GlideSafe HP (3) and Cable - 00841494108304 Catalog Number :

Device Description : 15mm GlideSafe HP (3) and Cable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

20mm GlideSafe HP (3) and Cable - 00841494108311 Catalog Number :

Device Description : 20mm GlideSafe HP (3) and Cable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

7.5mm GlideSafe HP (3) and Cable - 00841494108328 Catalog Number :

Device Description : 7.5mm GlideSafe HP (3) and Cable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LUXY HP, StarLux Repl. - 00841494108335 Catalog Number :

Device Description : LUXY HP, StarLux Repl.

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

LUXR HP, StarLux 500 Repl - 00841494108342 Catalog Number :

Device Description : LUXR HP, StarLux 500 Repl

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

MAXG HP, StarLux 500 Refurb - 00841494108359 Catalog Number :

Device Description : MAXG HP, StarLux 500 Refurb

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

ASSY, Final TempSure, Surgical, Refurb - 00841494108366 Catalog Number :

Device Description : ASSY, Final TempSure, Surgical, Refurb

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

2940 HP, Artisan - 00841494108373 Catalog Number :

Device Description : 2940 HP, Artisan

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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