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FDA 510(k)

Velacur One (LI-1100)

K-Number: K251728 · 2025-06-26

ApplicantSonic Incytes Medical Corp
Decision Date2025-06-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Velacur One (LI-1100) is a medical device manufactured by Sonic Incytes Medical Corp. It received FDA 510(k) clearance on 2025-06-26 under approval number K251728. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velacur One (LI-1100)?

Velacur One (LI-1100) is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Sonic Incytes Medical Corp. The 510(k) number is K251728.

When was Velacur One (LI-1100) approved by the FDA?

Velacur One (LI-1100) received FDA 510(k) clearance on 2025-06-26, under approval number K251728.

What company makes Velacur One (LI-1100)?

Velacur One (LI-1100) is manufactured by Sonic Incytes Medical Corp.

What is the FDA product code for Velacur One (LI-1100)?

The FDA product code for Velacur One (LI-1100) is IYO.

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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.

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