Identity
- Trade Name
- Ultravision2 Generator FDA UDI
- Generic Name
- Laparoscopic plume filter FDA UDI
- Device Name
- Ultravision2™ Generator EUDAMEDThe Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke. FDA UDI
- Model / Reference
- DPD-006-001 EUDAMEDFDA UDI
- Description
- The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke. FDA UDI
Identifiers
- Catalog Number
- DPD-006-001 FDA UDI
- Primary DI / UDI-DI
- 05060417680412 EUDAMEDFDA UDI
- Basic UDI-DI
- 506041768050604176804127D EUDAMED
- 510(k) Number
- K231238 FDA UDI
- FDA Product Code
- PQM FDA UDI
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Laparoscopic plume filter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5050 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laparoscopic plume filter
Ultravision2 Generator by Alesi Surgical, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alesi Surgical, Ltd.
Sources (2)
- FDA UDI efb8ed2c-a591-4719-808d-054140861ae7 36 fields · synced Jul 23, 2026
- EUDAMED 67e373ab-4cd8-4f37-9f64-5c7ada220e83 61 fields · synced Jul 23, 2026