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) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1)

Premarket Exempt

Clear

Applicator PRS 530 530 - 750 nm - 00817495023403 Catalog Number :

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Applicator Frax 1550 1550 nm - 00817495023410 Catalog Number :

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Applicator Frax 1940 1940 nm - 00817495023427 Catalog Number :

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Nordlys - 00817495023434 Catalog Number :

Device Description : Multi-modality skin surface treatment system: Intense Pulsed Light (IPL) and Laser device.

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Sirius - 00817495023441 Catalog Number :

Device Description : Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Nordlys System - 00817495023458 Catalog Number :

Device Description : Nordlys System - 200-240V China configuration

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX, ONF

Prescription Use : Yes

Device Count : 1

Frax Pro - 00817495023465 Catalog Number :

Device Description : Frax Pro

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Frax Pro System - CE Configuration - 00817495023472 Catalog Number :

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Frax 1940 - 00817495023489 Catalog Number :

Device Description : Frax 1940 ( Laser)

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Vbeam Perfecta - 00817495023496 Catalog Number : 9914-VT-0300

Device Description : Pulse Dye Laser

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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