Alesi Surgical, Ltd.
US Last updated 23 May 2026
- Devices
- 22
- Registries
- GUDIDEUDAMEDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
UltravisionTM Mains Converter Ref Mains Converter
UltravisionTM IonwandTM Sterile Pack Ref IonwandTM Sterile Pack
UltravisionTM System Starter Pack Ref UltravisionTM System Starter Pack
Ultravision2 IonPencil DPD-007-001 Ref DPD-007-001
UltravisionTM Ultravision Battery Recharging Station Ref Ultravision Battery Recharging Station
UltravsionTM Ultravision Battery (x2) Ref Ultravision Battery (x2)
UltravisionTM Patient Return Adaptor 1.5M (solid) Ref Patient Return Adaptor 1.5M (solid)
UltravisionTM Patient Return Adaptor Solid Ref Patient Return Adaptor Solid
UltravisionTM Patient Return Adaptor 1.5m (Split) Ref Patient Return Adaptor 1.5m (Split)
UltravisionTM Generator Ref UltravisionTM Generator
UltravisionTM Patient Return Adaptor 0.75m (Split) Ref Patient Return Adaptor 0.75m (Split)
UltravisionTM Ultravision TM 5mm Trocar Ref Ultravision TM 5mm Trocar
UltravisionTM UltravsionTM Power Supply Unit Ref UltravsionTM Power Supply Unit
Ultravision2 Integrated Monopolar L Hook (H/S) DPD-006-201 Ref DPD-006-201
Ultravision2 Generator DPD-006-001 Ref DPD-006-001
Ultravision Visual Field Clearing System Ref K170178
Ultravision2™ IonPencil Ref K240868
Ultravision Visual Field Clearing System Ref K200035
Ultravision Visual Clearing System Ref DEN150022
Ultravision2™ System Ref K231238
Ultravision™ Visual Field Clearing System Ref K182053
FDA establishments
- Alesi Surgical Ltd Cardiff · GB FEI 3012582478
What Alesi Surgical, Ltd. makes
Alesi Surgical, Ltd. manufactures systems for managing surgical fluid and smoke waste, including laparoscopic plume filters and evacuation systems designed to reduce airborne contaminants during procedures. Their portfolio includes devices like the Ultravision™ series, which are engineered to capture and filter surgical smoke and fluids during laparoscopic surgeries.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Alesi Surgical, Ltd. is based in the United States.
Frequently asked questions
What types of medical devices does Alesi Surgical, Ltd. manufacture?
Alesi Surgical, Ltd. specializes in surgical fluid and smoke waste management systems. Their primary products include laparoscopic plume filters and surgical plume evacuation systems, such as the Ultravision™ series. These devices are designed to minimize airborne contaminants like surgical smoke and fluids during procedures, particularly in laparoscopic surgeries.
Where is Alesi Surgical, Ltd. based?
Alesi Surgical, Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
Which regulatory registries list Alesi Surgical, Ltd.’s devices?
Alesi Surgical, Ltd.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track devices that have undergone the FDA’s 510(k) premarket notification process, ensuring they meet applicable regulatory requirements for safety and effectiveness.
How are Alesi Surgical, Ltd.’s devices classified under FDA regulations?
Alesi Surgical, Ltd.’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and performance, such as surgical plume evacuation systems and filters.
Information
- Country
- US