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) (2)

Premarket Exempt

No Yes

Clear

Accolade - 00841494100100 Catalog Number :

Device Description : Accolade Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Skintel Melanin Reader - 00841494100117 Catalog Number :

Device Description : Skintel Melanin Reader

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vectus - 00841494100124 Catalog Number :

Device Description : Vectus Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vectus Diode Handpiece - 00841494100131 Catalog Number :

Device Description : Vectus Diode Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Small Sapphire Optic - 00841494100148 Catalog Number :

Device Description : Vectus Small Sapphire Optic

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Large Sapphire Optic - 00841494100155 Catalog Number :

Device Description : Vectus Large Sapphire Optic

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Large Sapphire Optic - 00841494100162 Catalog Number :

Device Description : Vectus Large Sapphire Optic Refurbished

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Emerge - 00841494100179 Catalog Number :

Device Description : Emerge Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Emerge Handpiece - 00841494100186 Catalog Number :

Device Description : Emerge Handpiece Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG

Prescription Use : Yes

Device Count : 1

Medlite C6 - 00841494100193 Catalog Number :

Device Description : Medlite C6 115V Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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