FDA 510(k)

Ultravision Visual Field Clearing System

K-Number: K170178 · 2017-05-26

Decision Date2017-05-26

Product CodePQM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ultravision Visual Field Clearing System is a medical device manufactured by Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2017-05-26 under approval number K170178. 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 Ultravision Visual Field Clearing System?

Ultravision Visual Field Clearing System is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Alesi Surgical, Ltd.. The 510(k) number is K170178.

When was Ultravision Visual Field Clearing System approved by the FDA?

Ultravision Visual Field Clearing System received FDA 510(k) clearance on 2017-05-26, under approval number K170178.

What company makes Ultravision Visual Field Clearing System?

Ultravision Visual Field Clearing System is manufactured by Alesi Surgical, Ltd..

What is the FDA product code for Ultravision Visual Field Clearing System?

The FDA product code for Ultravision Visual Field Clearing System is PQM.

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Other Devices by Alesi Surgical, Ltd.

DEN150022Ultravision Visual Clearing System K182053Ultravision Visual Field Clearing System K200035Ultravision Visual Field Clearing System K231238Ultravision2 System K231298Ultravision2 System Integrated Monopolar L-Hook (H/S)

Related Devices (Code: PQM)

DEN150022Ultravision Visual Clearing SystemAlesi Surgical, Ltd. K182053Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. K200035Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. K231238Ultravision2 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.