📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Optional surface modification for implants, as described in the FDA 510(k) record.
- Use is limited to implants and clinical applications covered by the compatible implant's labeling and the manufacturer's instructions for use.
Clinical Applications
- Surface treatment of compatible implants before implantation.
- Use with implants in surgical procedures when the implant's labeling permits the Silhouette IC or Silhouette Laser-Lok modification.
Practical Considerations
- The surface modification is optional and should be used only with compatible implant models identified by the manufacturer.
- Confirm the implant size, material, configuration, and handling requirements before surgery.
- The supplied FDA summary does not provide enough information to determine MRI safety; review the implant-specific MRI labeling.
- Contraindications, warnings, sterilization requirements, and handling instructions should be taken from the current manufacturer labeling.
- The surface treatment does not replace treatment of the underlying condition or the implant's intended mechanical function.
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.