FDA 510(k)

Ultravision Visual Field Clearing System

K-Number: K182053 · 2018-09-07

Decision Date2018-09-07

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 2018-09-07 under approval number K182053. 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 2018-09-07. It is manufactured by Alesi Surgical, Ltd.. The 510(k) number is K182053.

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

Ultravision Visual Field Clearing System received FDA 510(k) clearance on 2018-09-07, under approval number K182053.

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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Related PubMed Literature

PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020) PMID: 25255810 Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. American journal of epidemiology (2014)

Other Devices by Alesi Surgical, Ltd.

DEN150022Ultravision Visual Clearing System K170178Ultravision 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. K170178Ultravision 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.