Identity
- Trade Name
- Lightbox L3 FDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- L300 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- L300 FDA UDI
- Primary DI / UDI-DI
- 00851354004509 FDA UDI
- 510(k) Number
- K212468 FDA UDI
- FDA Product Code
- NQQ FDA UDI
- GMDN Term
- Mechanical atherectomy system catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical atherectomy system catheter, peripheral
Lightbox L3 by Avinger, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system catheter, peripheral.
- Stealth — Cardiovascular Systems, Inc. · Class II
- DIAMONDBACK — Cardiovascular Systems, Inc. · Class II
- TurboHawk — Covidien LP · Class II
- SilverHawkTM — Covidien LP · Class II
- SilverHawk — Covidien LP · Class II
- HawkOne™ — Covidien LP · Class II
- SilverHawkTM — Covidien LP · Class II
- HawkOne — Covidien LP · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avinger, Inc.
Sources (1)
- FDA UDI 842dfc91-9e88-45cf-9a34-b06630e8c0ec 35 fields · synced May 31, 2026