Ablation systems
Visica 2
An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.
Visica 2 models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| VS3000 | — | Not stated | Available |
FDA clearances
- 510(k) K062896 January 2007
Procedures that use ablation systems
Frequently asked questions
What is Visica 2 used for?
An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.
Who makes Visica 2?
Visica 2 is made by Sanarus Technologies, Inc.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does Visica 2 come in?
The FDA device database does not list sizes for Visica 2. Check the instructions for use or ask a Sanarus Technologies, Inc. representative.
Is Visica 2 MRI safe?
The FDA device database entry for Visica 2 does not state its MRI safety status. Check the labeling before MRI.
Is Visica 2 FDA cleared?
Visica 2 is covered by FDA submission K062896.
How do I contact a Sanarus Technologies, Inc. sales representative?
Sanarus Technologies, Inc. has not listed representatives on LA Vascular yet. Visit the Sanarus Technologies, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.