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FDA 510(k)

Ultravision2™ IonPencil

K-Number: K240868 · 2024-08-12

ApplicantAlesi Surgical Limited
Decision Date2024-08-12
Product CodePQM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultravision2™ IonPencil is the device name listed in this FDA 510(k) record. The listed applicant is Alesi Surgical Limited. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K240868. 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™ IonPencil?

Ultravision2™ IonPencil is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Alesi Surgical Limited. The 510(k) number is K240868.

When did Ultravision2™ IonPencil receive FDA 510(k) clearance?

Ultravision2™ IonPencil received FDA 510(k) clearance on 2024-08-12, under 510(k) number K240868.

Who is the listed applicant for Ultravision2™ IonPencil?

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

What is the FDA product code for Ultravision2™ IonPencil?

The FDA product code for Ultravision2™ IonPencil is PQM.

Other records listing Alesi Surgical Limited 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.

K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™K231238Ultravision2™ SystemK200035Ultravision Visual Field Clearing 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.

K231298Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd.K231238Ultravision2™ SystemAlesi Surgical, Ltd.K200035Ultravision Visual Field Clearing 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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