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Ultravision2 Integrated Monopolar L Hook (H/S)

FDA UDI

Class II (US FDA UDI)

by Alesi Surgical, Ltd.

Identity

Trade Name
Ultravision2 Integrated Monopolar L Hook (H/S) FDA UDI
Generic Name
Laparoscopic plume filter FDA UDI
Device Name
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. FDA UDI
Model / Reference
DPD-006-201 FDA UDI
Description
The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostatic precipitation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. FDA UDI

Identifiers

Catalog Number
DPD-006-201 FDA UDI
Primary DI / UDI-DI
05060417680467 FDA UDI
510(k) Number
K231298 FDA UDI
FDA Product Code
PQM FDA UDI
GEI FDA UDI
GMDN Term
Laparoscopic plume filter 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

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laparoscopic plume filter

Ultravision2 Integrated Monopolar L Hook (H/S) by Alesi Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic plume filter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alesi Surgical, Ltd.

Sources (1)

  • FDA UDI 592948f7-028f-41bf-be33-306addfade2b 36 fields · synced May 31, 2026