Identity
- Trade Name
- DABRA Laser System FDA UDI
- Generic Name
- Atherectomy excimer laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RA-308 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842362100024 FDA UDI
- 510(k) Number
- K170349 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Atherectomy excimer laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Atherectomy excimer laser system
DABRA Laser System by Catheter Precision, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy excimer laser system.
- CVX-300®-P — Spectranetics Corporation · Class III
- Excimer Laser System — Spectranetics Corporation · Class III
- Excimer Laser System — Spectranetics Corporation · Class III
Cleared under the same submission
K170349 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Catheter Precision, Inc
Sources (1)
- FDA UDI 6c63ea01-11e9-4360-83e5-838e42d74bbb 34 fields · synced May 31, 2026