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modification to silhouette ic or silhouette laser-lok surface treatment -optional surface modification to implants
Bio-Lok Intl.
Summary: The Silhouette IC or Laser-Lok is a surface modification for implants used in tumor ablation. It is utilized by specialists in oncology and surgical settings.
FDA Clearance Information
Pathway
510K
Number
K041136 ↗
Decision Date
October 22, 2004
Product Code
DZE
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 22, 2004. Manufactured by Bio-Lok Intl., it is classified as a Class 2 device under product code DZE.
What It Is
The Silhouette IC or Laser-Lok is an optional surface treatment applied to implants, enhancing their integration and performance. It is designed to modify the surface characteristics of implants used in tumor ablation procedures. This surface modification aims to improve the biological response and stability of the implant within the body.
Clinical Applications
Commonly used in oncology, this device is applied in surgical settings where tumor ablation is performed. It is particularly relevant for patients undergoing procedures to remove or reduce tumors. The device is used by surgical oncologists and interventional radiologists in hospitals and specialized cancer treatment centers.
Indications for Use
The device is indicated for use in patients requiring implants for tumor ablation procedures. It is suitable for conditions where enhanced implant integration is beneficial, such as in the treatment of solid tumors.
Practical Considerations
The device is compatible with various implant sizes and types, allowing for flexibility in different clinical scenarios. Clinicians should consider the specific implant compatibility and the surgical technique required for optimal results.
Frequently Asked Questions
What is Silhouette IC/Laser-Lok used for?
It is used for modifying the surface of implants in tumor ablation procedures to enhance integration and performance.
What specialties typically use this device?
This device is typically used by surgical oncologists and interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures requiring implants with enhanced surface characteristics.
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.