Identifiers
- 510(k) Number
- K123467 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VS3 is a fluorescence imaging system designed for visualizing internal surgical sites during endoscopic and laparoscopic procedures. It employs indocyanine green (ICG) fluorescence to enhance visualization of vessels, blood flow, and tissue perfusion, aiding in real-time surgical assessment.
The VS3 is supplied as a reusable medical device and is intended for use in general surgical, plastic, micro-, and reconstructive procedures. It operates under FDA 510(k) clearance (K123467) and is classified under product code GCJ, adhering to regulatory standards for endoscopic accessories. Sterility and MRI safety are not specified in the provided data.
Frequently asked questions
What types of surgical procedures can the VS3 fluorescence imaging system assist with during real-time visualization?
The VS3 is designed to assist in general surgical, plastic, micro-, and reconstructive procedures by enhancing visualization of internal sites using indocyanine green (ICG) fluorescence. This helps surgeons assess vessels, blood flow, and tissue perfusion during endoscopic and laparoscopic surgeries, improving precision and decision-making.
Is the VS3 system reusable, and if so, what does this mean for maintenance and longevity?
Yes, the VS3 is supplied as a reusable medical device. This means it is intended for repeated use across multiple procedures, though proper cleaning, sterilization (if applicable), and maintenance are critical to ensure performance, safety, and longevity. The manufacturer’s instructions should be followed to uphold functionality and regulatory compliance.
How does the VS3’s FDA clearance (K123467) relate to its intended use, and what does the product code GCJ signify?
The VS3 holds FDA 510(k) clearance under reference number K123467, indicating it has been deemed *substantially equivalent* to a legally marketed device in its category. The product code GCJ classifies it under *endoscopic accessories*, aligning with its use in endoscopic and laparoscopic procedures. This classification reflects its regulatory filing route rather than clinical indications.
What advisory committees were involved in the VS3’s FDA review, and how might this impact its clinical applications?
The VS3’s review was overseen by the Gastroenterology and Urology (GU) advisory committees, as well as the Surgical Devices (SU) review panel. These committees provide specialized input on devices used in endoscopic and surgical procedures, ensuring the VS3’s design and performance meet standards for visualizing internal structures during procedures like those in plastic, reconstructive, or micro-surgery.
Since the VS3 uses fluorescence imaging with ICG, does this mean it can be safely used in MRI environments?
The provided data does not specify whether the VS3 is MRI-safe or compatible with magnetic resonance imaging environments. If MRI compatibility is required for your facility, you should consult the manufacturer’s documentation or contact Visionsense Ltd. directly for clarification, as this is critical for patient safety and equipment integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Visionsense Ltd. Guy Wroclawski Senior Regulatory Affairs Specialist, VS3 by VISIONSENSE, LTD. | FDA 510 (k) Summary, PDF Visionsense Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123467 | Class II | Active |
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Manufacturer
- Manufacturer
- Visionsense Ltd.
- FDA Applicant
- Visionsense, Ltd.
Sources (1)
- FDA 510(k) K123467 24 fields · synced Sep 19, 2026