Lightbox L3
Basic Information
- Brand Name
- Lightbox L3
- Primary DI
- 00851354004509
- Version / Model
- L300
- Catalog Number
- L300
- Company Name
- AVINGER, INC.
- Labeler DUNS
- 003152968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-29
- Public Version
- 1
- Public Version Date
- 2024-02-06
- Public Version Status
- New
- Public Device Record Key
- 842dfc91-9e88-45cf-9a34-b06630e8c0ec
Device Description
The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and the Pantheris atherectomy catheter system. The Lightbox 3 console is intended to be used in conjunction with compatible Avinger catheter products by means of an accessory Sled interface to facilitate spinning of fibers at the distal ends of catheters. The Lightbox 3 console houses a laser light source and transmits light to the intraluminal environment through an optical fiber in compatible Avinger products. The Lightbox 3 console receives and interprets the reflected light using a computer to analyze the reflected signal that is returned and processes it in order to present an OCT image of the vessel on the operator monitor in real time.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44307 | Mechanical atherectomy system catheter, peripheral | A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851354004509 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212468 | 000 |