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) (3) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

Clear

Cbeam 10MM Handpiece Assembly - 08174950202202 Catalog Number :

Device Description : Handpiece Assembly

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Cbeam 5MM Handpiece Assembly - 08174950202219 Catalog Number :

Device Description : Handpiece Assembly

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Cbeam 7MM Handpiece Assembly - 08174950202226 Catalog Number :

Device Description : Handpiece Assembly

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Matrix Pro Cartridge box (pack of 7) - 47290109952961 Catalog Number :

Device Class : 2

Duns Number: 053468385

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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