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 a medical device manufactured by Alesi Surgical Limited. It received FDA 510(k) clearance on 2024-08-12 under approval 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. It is manufactured by Alesi Surgical Limited. The 510(k) number is K240868.
When was Ultravision2 IonPencil approved by the FDA?
Ultravision2 IonPencil received FDA 510(k) clearance on 2024-08-12, under approval number K240868.
What company makes Ultravision2 IonPencil?
Ultravision2 IonPencil is manufactured by Alesi Surgical Limited.
What is the FDA product code for Ultravision2 IonPencil?
The FDA product code for Ultravision2 IonPencil is PQM.
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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.