Ultravision2 IonPencil

FDA UDI

Class II (US FDA UDI)

by Alesi Surgical, Ltd.

Identity

Trade Name: Ultravision2 IonPencil FDA UDI
Generic Name: Surgical plume evacuation system FDA UDI
Device Name: The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory. FDA UDI
Model / Reference: DPD-007-001 FDA UDI
Description: The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory. FDA UDI

Identifiers

Catalog Number: DPD-007-001 FDA UDI
Primary DI / UDI-DI: 05060417680498 FDA UDI
510(k) Number: K240868 FDA UDI
FDA Product Code: PQM FDA UDI
GEI FDA UDI
GMDN Term: Surgical plume evacuation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5050 FDA UDI
878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical plume evacuation system

Ultravision2 IonPencil by Alesi Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Alesi Surgical, Ltd.

Sources (1)

FDA UDI 08c83974-0b88-4235-a552-efd371de9475 36 fields · synced May 30, 2026