Candela Corporation

Candela Corporation

Address:251 Locke Drive,Marlborough,MA,01752,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)

Premarket Exempt

No

Clear

Vbeam Perfecta - 00817495020006 Catalog Number :

Device Description : Pulse Dye Laser

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleMax Pro - 00817495020013 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Perfecta - 00817495020020 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PicoWay - 00817495020037 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleYAG Pro-U - 00817495020044 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ALEX TriVantage - 00817495020051 Catalog Number : 9914-00-2025

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleLASE - 00817495020068 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleLASE Pro - 00817495020075 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleLASE Pro-U - 00817495020082 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleLASE - 00817495020099 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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