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) Powered laser surgical instrument with microbeam\fractional output (ONG) (6)

Premarket Exempt

No Yes

Clear

Medlite C6 - 00841494100209 Catalog Number :

Device Description : Medlite C6 220V Laser Assembly

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Revlite System, 220V + - 00841494100216 Catalog Number :

Device Description : Revlite System, 220V +

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

RevLite II System 220V - 00841494100223 Catalog Number :

Device Description : RevLite II System 220V

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ASSY, FOCUS ARRAY, PICO300 - 00841494100230 Catalog Number :

Device Description : ASSY, FOCUS ARRAY, PICO300

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

1540 handpiece - 00841494100247 Catalog Number :

Device Description : 1540 handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

2940 handpiece - 00841494100254 Catalog Number :

Device Description : 2940 handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

1064+ Handpiece - 00841494100261 Catalog Number :

Device Description : 1064+ Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

Max G Handpiece - 00841494100278 Catalog Number :

Device Description : Max G Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

Max R Handpiece - 00841494100285 Catalog Number :

Device Description : Max R Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : Yes

Device Count : 1

Max Rs Handpiece - 00841494100292 Catalog Number :

Device Description : Max Rs Handpiece

Device Class : 2

Duns Number: 780318028

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : Yes

Device Count : 1

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