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

Premarket Exempt

No Yes

Clear

Spacer tip for 532 Handpiece - 00841494100568 Catalog Number :

Device Description : Spacer tip for 532 Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Handpiece tip, reusable - 00841494100575 Catalog Number :

Device Description : Cynergy PDL Handpiece tip, reusable

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Focal Guide 6 x 6 - 00841494100582 Catalog Number :

Device Description : Focal Guide 6 x 6

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

Focal Guide 10 x 10 - 00841494100599 Catalog Number :

Device Description : Focal Guide 10 x 10

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

Skintel Melanin Reader - 00841494100605 Catalog Number :

Device Description : Skintel Melanin Reader Remanufactured

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vectus Diode Handpiece - 00841494100612 Catalog Number :

Device Description : Vectus Handpiece Refurbished

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Emerge - 00841494100629 Catalog Number :

Device Description : Emerge remanufactured

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Small Sapphire Optic - 00841494100636 Catalog Number :

Device Description : Vectus Small Sapphire Optic Refurbished

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Emerge Handpiece - 00841494100643 Catalog Number :

Device Description : Emerge Handpiece Remanufactured

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

1541 handpiece - 00841494100650 Catalog Number :

Device Description : 1540 Handpiece Remanufactured

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

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