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

Clear

GentleLASE Limited Edition - 00817495020105 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleYAG - 00817495020112 Catalog Number :

Device Description : Pulsed Laser Previous DI: 08174950200116

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleYAG - 00817495020129 Catalog Number :

Device Description : Pulsed Laser Previous DI: 08174950200123

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Perfecta - 00817495020136 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Platinum - 00817495020143 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Aesthetica - 00817495020150 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Platinum - 00817495020167 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Vbeam Aesthetica - 00817495020174 Catalog Number :

Device Description : Pulsed Laser

Device Class :

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleMax - 00817495020181 Catalog Number :

Device Description : Pulsed Laser

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GentleMax - 00817495020198 Catalog Number :

Device Description : Pulsed Laser

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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