FDA 510(k)

Ultravision2 System

K-Number: K231238 · 2023-10-31

Decision Date2023-10-31

Product CodePQM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ultravision2 System is a medical device manufactured by Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231238. The device is classified under product code PQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultravision2 System?

Ultravision2 System is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Alesi Surgical, Ltd.. The 510(k) number is K231238.

When was Ultravision2 System approved by the FDA?

Ultravision2 System received FDA 510(k) clearance on 2023-10-31, under approval number K231238.

What company makes Ultravision2 System?

Ultravision2 System is manufactured by Alesi Surgical, Ltd..

What is the FDA product code for Ultravision2 System?

The FDA product code for Ultravision2 System is PQM.

Other Devices by Alesi Surgical, Ltd.

DEN150022Ultravision Visual Clearing System K170178Ultravision Visual Field Clearing System K182053Ultravision Visual Field Clearing System K200035Ultravision Visual Field Clearing System K231298Ultravision2 System Integrated Monopolar L-Hook (H/S)

Related Devices (Code: PQM)

DEN150022Ultravision Visual Clearing SystemAlesi Surgical, Ltd. K170178Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. K182053Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. K231298Ultravision2 System Integrated Monopolar L-Hook (H/S)Alesi Surgical, Ltd. K240868Ultravision2 IonPencilAlesi Surgical Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.