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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 510K
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.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Megabeam Ceralas is employed in procedures involving the portal vein. It is suitable for patients requiring minimally invasive treatment for vascular conditions. The device is often used in hospital settings, particularly in operating rooms and specialized radiology suites.
Indications for Use
The device is indicated for use in procedures involving the portal vein, which may include treatment of portal hypertension or other vascular abnormalities. It is suitable for patients with specific vascular conditions requiring precise laser intervention.
Practical Considerations
The Megabeam Ceralas handpiece is compatible with a range of disposable tips, allowing for flexibility in different procedures. Clinicians should ensure proper calibration and maintenance of the device for optimal performance. Familiarity with laser safety protocols is essential for safe operation.
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.