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nano varnish plaquit lightpaint on surface
Dreve Dentamid
Summary: The Nano Varnish Plaquit Lightpaint is a medical device used for tumor ablation. It is primarily used by oncologists and surgeons in clinical settings to treat specific tumor conditions.
FDA Clearance Information
Pathway
510K
Number
K162408 ↗
Decision Date
April 5, 2018
Product Code
EBD
Device Class
Class 2
Evidence
0 studies
The Nano Varnish Plaquit Lightpaint was cleared through the FDA 510k pathway on April 5, 2018. Manufactured by Dreve Dentamid, it is classified as a Class 2 device under product code EBD.
What It Is
The Nano Varnish Plaquit Lightpaint is an advanced medical device designed for the ablation of tumors. It utilizes a specialized light-based technology to target and ablate tumor cells effectively. This device is engineered to provide precise control over the ablation process, minimizing damage to surrounding healthy tissues.
Clinical Applications
This device is commonly used in oncology and surgical settings for the treatment of tumors. It is particularly useful in procedures where precision is critical, such as in the ablation of small or difficult-to-reach tumors. Oncologists and surgeons may employ this device in both hospital and outpatient settings, catering to adult patients with specific tumor types.
Indications for Use
The FDA-cleared indications for the Nano Varnish Plaquit Lightpaint involve its use in the ablation of tumors. It is intended for patients who require targeted tumor treatment, offering a minimally invasive option for tumor management.
Practical Considerations
Clinicians should consider the compatibility of this device with existing surgical equipment and ensure proper training in its use. The device may come in different sizes to accommodate various tumor sizes and locations, and it requires specific light-based techniques for optimal results.
Frequently Asked Questions
What is Nano Varnish Plaquit Lightpaint used for?
It is used for the ablation of tumors, providing a minimally invasive treatment option.
What specialties typically use this device?
Oncology and surgical specialties primarily use this device for tumor treatment.
What are the FDA-cleared indications?
The device is indicated for the ablation of tumors, offering targeted treatment for specific tumor conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.