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ems surface mount scaler
(Ems Sa) Electro Medical Systems
Summary: The EMS Surface Mount Scaler is a medical device used for tumor ablation. It is primarily used by clinicians in oncology and surgical specialties.
FDA Clearance Information
Pathway
510K
Number
K991874 ↗
Decision Date
July 30, 1999
Product Code
ELC
Device Class
Class 2
Evidence
0 studies
The EMS Surface Mount Scaler was cleared through the FDA 510k pathway on July 30, 1999. It is manufactured by Ems Sa and classified as a Class 2 device.
What It Is
The EMS Surface Mount Scaler is a device designed for the ablation of tumors. It employs surface mount technology to deliver precise energy to targeted tissues, effectively reducing or eliminating tumor mass. This device is typically used in minimally invasive procedures, offering a less traumatic option compared to traditional surgical methods.
Clinical Applications
This device is commonly used in oncology settings for the treatment of solid tumors. It is suitable for use in both outpatient and inpatient settings, depending on the complexity of the procedure. The device is particularly beneficial for patients who are not candidates for open surgery due to health constraints or tumor location.
Indications for Use
The FDA indications for the EMS Surface Mount Scaler include its use in the ablation of tumors. This means it is intended for patients with solid tumors that require reduction or removal through minimally invasive techniques.
Practical Considerations
The EMS Surface Mount Scaler is compatible with standard surgical equipment and requires minimal setup. Clinicians should be trained in its use to ensure optimal outcomes. The device's compact design allows for easy integration into existing surgical suites.
Frequently Asked Questions
What is the EMS Surface Mount Scaler used for?
It is used for the ablation of tumors, providing a minimally invasive option for tumor reduction or removal.
What specialties typically use this device?
Oncology and surgical specialties commonly use this device, particularly in settings focused on tumor treatment.
What are the FDA-cleared indications?
The device is cleared for the ablation of tumors, targeting solid tumors requiring minimally invasive intervention.
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.