đź“‹ FDA Reference
Megabeam Ceralas Reuseable Handpiece and Disposable TIPS
Biolitec
Summary: The Megabeam Ceralas is a reusable handpiece with disposable tips used in portal vein procedures. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010804 ↗
Decision Date ?
October 4, 2001
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Megabeam Ceralas was cleared via the FDA 510(k) pathway on October 4, 2001. Manufactured by Biolitec, it is classified as a Class 2 medical device.
What It Is
The Megabeam Ceralas is a laser-based medical device consisting of a reusable handpiece and disposable tips. It is designed to deliver precise laser energy for therapeutic interventions, particularly in vascular procedures. The device's design allows for targeted treatment, minimizing damage to surrounding tissues.
FDA-Cleared Indications
- Use in procedures involving the portal vein, as described in the available FDA record.
Clinical Applications
- Delivery of laser energy during portal-vein procedures.
- Use by trained clinicians during minimally invasive vascular interventions involving the portal vein.
Practical Considerations
- The system includes a reusable handpiece and disposable tips; tip compatibility depends on the specific Ceralas configuration and procedure.
- The available record does not specify tip sizes, laser wavelength, power settings, or treatment durations; clinicians should follow the applicable labeling and instructions for use.
- Laser safety precautions, including appropriate eye protection and controlled access to the treatment area, are required.
- The handpiece requires cleaning, inspection, calibration, and maintenance according to manufacturer instructions between uses.
- MRI safety status is not established in the supplied record. Confirm the handpiece and tip's MR labeling before use in or near an MRI environment.
Frequently Asked Questions
What is the Megabeam Ceralas used for?
It is used for laser-based interventions in the portal vein, often in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as treating vascular 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.