Ablation systems
Hygea
by Hygea Medical Technology Co., Ltd.
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.
Hygea 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 |
|---|---|---|---|
| AI Epic S20U | — | MR Unsafe | Available |
| AI Epic S40U | — | MR Unsafe | Available |
| Ease TML15 | — | MR Unsafe | Available |
| Ease TML15A | — | MR Unsafe | Available |
| Ease TMS15 | — | MR Unsafe | Available |
| Ease TSL08 | — | MR Unsafe | Available |
| Ease TSL08A | — | MR Unsafe | Available |
| Ease TSS08 | — | MR Unsafe | Available |
| Elite ABL20 | — | MR Unsafe | Available |
| Elite ABS20 | — | MR Unsafe | Available |
| Elite ABX20 | — | MR Unsafe | Available |
| Elite ACL17 | — | MR Unsafe | Available |
| Elite ACS17 | — | MR Unsafe | Available |
| Elite ACX17 | — | MR Unsafe | Available |
| Elite ADL26 | — | MR Unsafe | Available |
| Elite RAL26 | — | MR Unsafe | Available |
| Elite RAL30 | — | MR Unsafe | Available |
| Elite RAS26 | — | MR Unsafe | Available |
| Elite RAS30 | — | MR Unsafe | Available |
| Elite RBL20 | — | MR Unsafe | Available |
| Elite RBL26 | — | MR Unsafe | Available |
| Elite RBS20 | — | MR Unsafe | Available |
| Elite RBS26 | — | MR Unsafe | Available |
| Elite RBX20 | — | MR Unsafe | Available |
| Elite RBX26 | — | MR Unsafe | Available |
| Elite RCL17 | — | MR Unsafe | Available |
| Elite RCS17 | — | MR Unsafe | Available |
| Elite RCX17 | — | MR Unsafe | Available |
| Exact HC-1414250U | — | MR Unsafe | Available |
| Exact HC-1514150U | — | MR Unsafe | Available |
| Exact HC-1514200U | — | MR Unsafe | Available |
| Exact HC-1614150U | — | MR Unsafe | Available |
| Exact HC-1614200U | — | MR Unsafe | Available |
| Exact HC-1814100U | — | MR Unsafe | Available |
| Exact HC-1814150U | — | MR Unsafe | Available |
| Exact HC-1814200U | — | MR Unsafe | Available |
| Exact HP-1507200U | — | MR Unsafe | Available |
| Exact HP-1512200U | — | MR Unsafe | Available |
| Exact HP-1605100U | — | MR Unsafe | Available |
| Exact HP-1805080U | — | MR Unsafe | Available |
| Exact HS-1425150U | — | MR Unsafe | Available |
| Exact HS-1425200U | — | MR Unsafe | Available |
| Exact HT-1414200U | — | MR Unsafe | Available |
| Exceed S10U | — | MR Unsafe | Available |
FDA clearances
- 510(k) K243042 January 2025
- 510(k) K233140 January 2024
Procedures that use ablation systems
Frequently asked questions
What is Hygea 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 Hygea?
Hygea is made by Hygea Medical Technology Co., Ltd.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does Hygea come in?
The FDA device database does not list sizes for Hygea. Check the instructions for use or ask a Hygea Medical Technology Co., Ltd. representative.
Is Hygea MRI safe?
The FDA device database lists Hygea as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Hygea FDA cleared?
Hygea is covered by FDA submissions K243042, K233140.
How do I contact a Hygea Medical Technology Co., Ltd. sales representative?
Hygea Medical Technology Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Hygea Medical Technology Co., Ltd. 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.