Lightbox L3 L300

GUDID 00851354004509

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.

AVINGER, INC.

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• Primary Device ID: 00851354004509
• NIH Device Record Key: 842dfc91-9e88-45cf-9a34-b06630e8c0ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightbox L3
• Version Model Number: L300
• Catalog Number: L300
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212468

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-06
• Device Publish Date: 2024-01-29

Devices Manufactured by AVINGER, INC.

• 00851354004509 - Lightbox L3: 2024-02-06The 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.
• 00851354004509 - Lightbox L3: 2024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de
• 00851354004578 - Pantheris LV: 2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F
• 00851354004554 - Tigereye ST: 2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions
• 00851354004493 - Tigereye: 2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
• 00851354004417 - Pantheris SV: 2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature
• 00851354004004 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004028 - Wildcat: 2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
• 00851354004042 - Kittykat II: 2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It