RA MEDICAL SYSTEMS, INC.

Address:2070 Las Palmas Drive,CARLSBAD,CA,92011,US

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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

Catheter For Crossing Total Occlusions (PDU) (2) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

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Pharos - 00842362100017 Catalog Number :

Device Description : A mains electricity (AC-powered) Light Amplification by Stimulated Emission of R A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma

Device Class : 2

Duns Number: 131845013

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DABRA Laser System - 00842362100024 Catalog Number :

Device Description : A mains electricity (AC-powered) Light Amplification by Stimulated Emission of R A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease.

Device Class : 2

Duns Number: 131845013

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

DABRA 101 Catheter - 00842362100031 Catalog Number :

Device Description : Percutaneous Catheter

Device Class : 2

Duns Number: 131845013

Premarket Exempt : No

Product Code : PDU

Prescription Use : Yes

Device Count : 1

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