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FDA 510(k)

Ultravision Visual Field Clearing System

K-Number: K200035 · 2020-05-04

ApplicantAlesi Surgical, Ltd.
Decision Date2020-05-04
Product CodePQM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultravision Visual Field Clearing System is the device name listed in this FDA 510(k) record. The listed applicant is Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K200035. 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 2020-05-04. The listed applicant is Alesi Surgical, Ltd.. The 510(k) number is K200035.

When did Ultravision Visual Field Clearing System receive FDA 510(k) clearance?

Ultravision Visual Field Clearing System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K200035.

Who is the listed applicant for Ultravision Visual Field Clearing System?

The FDA 510(k) record lists Alesi Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Alesi Surgical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240868Ultravision2™ IonPencilK231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™K231238Ultravision2™ SystemK182053Ultravision™ Visual Field Clearing SystemK170178Ultravision Visual Field Clearing System

Related Devices (Code: PQM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240868Ultravision2™ IonPencilAlesi Surgical LimitedK231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd.K231238Ultravision2™ SystemAlesi Surgical, Ltd.K182053Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd.K170178Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd.

Official Source

View on FDA Database →

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

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